DELTA CER INSERT 32ID X 50OD
Report
- Report Number
- 1818910-2024-11602
- Event Type
- Injury
- Date Received
- May 28, 2024
- Date of Event
- May 9, 2024
- Report Date
- May 28, 2024
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- MRA
- UDI-DI
- 10603295423263
- PMA / PMN Number
- P070026
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, ¿HCP IS REPORTING A FRACTURED CERAMIC HIP COMPONENT LEFT SIDE. SEE X-RAYS. WE WOULD HAVE A PATIENT ON TUESDAY (14.5.24) WHO HAS A BROKEN CERAMIC INLAY OR HEAD¿. THE PRODUCT RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE ALONG WITH A MANUFACTURING INVESTIGATION PERFORMED BY SUPPLIER. FURTHER DETAILS OF THE DEVICE'S ANALYSIS WERE ATTACHED ON "240808 FINAL REPORT KIV 24 06 11.PDF". VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT DELTA CER INSERT 32ID X 50OD HAS FRACTURE INTO TWO (2) SMALL AND ELEVEN (11) VERY SMALL FRAGMENTS. HOWEVER, THE CERAMIC LINER CANNOT BE COMPLETELY RECONSTRUCTED; THERE ARE FRAGMENTS MISSING WHICH COULD POTENTIALLY YIELD FURTHER INFORMATION IF THEY WERE AVAILABLE. METAL TRANSFER OF ERRATIC APPEARANCE WERE FOUND ON THE OUTER, INNER AND AROUND THE FRACTURE SURFACES. THE OBSERVED SECONDARY TRANSFER IS TYPICALLY CAUSED BY CHAFING BETWEEN METAL PARTS AND BROKEN FRAGMENTS OF CERAMIC, EITHER AFTER THE PRIMARY FRACTURE EVENT OR DURING THE SURGICAL PROCEDURES. IN CASE OF A SYMMETRICAL TAPER FIT BETWEEN THE CERAMIC LINER AND THE ACETABULAR CUP, METAL TRANSFER ARE EXPECTED AROUND THE WHOLE CIRCUMFERENCE OF THE CENTER AND TOP SECTION OF THE TAPER. SUCH PATTERNS WERE NOT FOUND ON THE REPORTED LINER; WHICH COULD INDICATE A INSUFFICIENT OR MISALIGNED FIXATION OF THE CERAMIC LINER IN THE CUP. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [121882750 / 4029764] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING. THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFIL REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE IS NO INDICATION OF ANY PRE -EXISTING MATERIAL DEFECT. ADDITIONALLY, THE DENSITY WAS DETERMINED ON THE FRAGMENTS OF THE LINER. THE MEASURED AVERAGE RELATIVE BULK DENSITY COMPLIES WITH THE DELIVERY SPECIFICATION FOR BIOLOX DELTA COMPONENTS (= 99%). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALTHOUGH THE LINER FAILURE CANNOT BE TRACED TO DESIGN OR MANUFACTURING, A DEFINITE ROOT CAUSE CANNOT BE ESTABLISHED DUE TO THERE BEING MULTIPLE FACTORS. CONSIDERATION MUST BE GIVEN TO ALL POTENTIAL INFLUENCES SUCH AS SURGICAL PROCESS, PATIENT VARIABLES (E.G. ACTIVITY LEVEL AND USE), ANATOMICAL CONSIDERATIONS AND PATIENT CHANGES OVER TIME. ANY CONCLUSIONS FROM THE INVESTIGATIONAL INPUT PROVIDED HAVE TO BE PLACED INTO CONTEXT WITH ALL OTHER RELEVANT FACTORS. IT IS HIGHLY RECOMMENDED TO THE PATIENT TO CONSULT WITH THEIR HEALTHCARE PROFESSIONAL FOR FURTHER ASSESSMENT. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE DELTA CER INSERT 32ID X 50OD WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: PROTOCOLS AND ACCEPTANCE CERTIFICATE WERE REVIEWED. THE QUALITY DOCUMENTS SHOWS THAT THE DATA OBTAINED ON THE CERAMIC LINER CONFORMED TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFIL REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE IS NO INDICATION OF ANY PRE-EXISTING MATERIAL DEFECT. 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 10-JAN-2023. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NONE. 4) EXPIRY DATE: 12-2027. 5) IFU REFERENCE: IFU-78002788. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [121882750 / 4029764] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING.
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : ACCORDING TO THE INFORMATION RECEIVED, ¿HCP IS REPORTING A FRACTURED CERAMIC HIP COMPONENT LEFT SIDE. SEE X-RAYS. WE WOULD HAVE A PATIENT ON TUESDAY (14.5.24) WHO HAS A BROKEN CERAMIC INLAY OR HEAD¿. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER RADIOLOGICAL IMAGES WERE PROVIDED FOR REVIEW. (B)(4). REVIEW OF THE RADIOLOGICAL IMAGE EVIDENCE REVEALED MULTIPLE BROKEN CERAMIC FRAGMENTS NEAR THE FEMORAL HEAD MOST LIKELY FROM THE DELTA CER INSERT 32ID X 50OD. NO OTHER DEFECTS CAN BE RETRIEVED FORM THE PROVIDED EVIDENCE. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. WITH THE INFORMATION PROVIDED IS NOT POSSIBLE TO DETERMINE A POTENTIAL CAUSE AT THIS MOMENT, HOWEVER IN SUPPORT OF THE EVALUATION PERFORMED. THE MODE OF FAILURE OF THE DEVICE IS MULTI-FACTORIAL AND CONSIDERATION MUST BE GIVEN TO ALL OTHER POTENTIAL INFLUENCES SUCH AS SURGICAL PROCESS, PATIENT VARIABLES (E.G. ACTIVITY LEVEL AND USE), ANATOMICAL CONSIDERATIONS AND PATIENT CHANGES OVER TIME. ANY CONCLUSIONS FROM THE INVESTIGATIONAL INPUT PROVIDED HAVE TO BE PLACED INTO CONTEXT WITH ALL OTHER RELEVANT FACTORS. IT IS HIGHLY RECOMMENDED TO THE PATIENT TO CONSULT WITH THEIR HEALTHCARE PROFESSIONAL FOR FURTHER ASSESSMENT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [121882750 / 4029764] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE DELTA CER INSERT 32ID X 50OD WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT : 1) QUANTITY MANUFACTURED: (B)(4), 2) DATE OF MANUFACTURE: 10-JAN-2023, 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NONE, 4) EXPIRY DATE: 12-2027, 5) IFU REFERENCE: IFU-78002788. DEVICE HISTORY REVIEW : A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [121882750 / 4029764] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING. CORRECTED: D4 PRIMARY UDI NUMBER.
PRODUCT COMPLAINT #:(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, ¿HCP IS REPORTING A FRACTURED CERAMIC HIP COMPONENT LEFT SIDE. SEE X-RAYS. WE WOULD HAVE A PATIENT ON TUESDAY (14.5.24) WHO HAS A BROKEN CERAMIC INLAY OR HEAD¿. THE PRODUCT RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE ALONG WITH A MANUFACTURING INVESTIGATION PERFORMED BY SUPPLIER. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT DELTA CER INSERT 32ID X 50OD HAS FRACTURE INTO TWO (2) SMALL AND ELEVEN (11) VERY SMALL FRAGMENTS. HOWEVER, THE CERAMIC LINER CANNOT BE COMPLETELY RECONSTRUCTED; THERE ARE FRAGMENTS MISSING WHICH COULD POTENTIALLY YIELD FURTHER INFORMATION IF THEY WERE AVAILABLE. METAL TRANSFER OF ERRATIC APPEARANCE WERE FOUND ON THE OUTER, INNER AND AROUND THE FRACTURE SURFACES. THE OBSERVED SECONDARY TRANSFER IS TYPICALLY CAUSED BY CHAFING BETWEEN METAL PARTS AND BROKEN FRAGMENTS OF CERAMIC, EITHER AFTER THE PRIMARY FRACTURE EVENT OR DURING THE SURGICAL PROCEDURES. IN CASE OF A SYMMETRICAL TAPER FIT BETWEEN THE CERAMIC LINER AND THE ACETABULAR CUP, METAL TRANSFER ARE EXPECTED AROUND THE WHOLE CIRCUMFERENCE OF THE CENTER AND TOP SECTION OF THE TAPER. SUCH PATTERNS WERE NOT FOUND ON THE REPORTED LINER; WHICH COULD INDICATE A INSUFFICIENT OR MISALIGNED FIXATION OF THE CERAMIC LINER IN THE CUP. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [121882750 / 4029764] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING. THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFIL REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE IS NO INDICATION OF ANY PRE -EXISTING MATERIAL DEFECT. ADDITIONALLY, THE DENSITY WAS DETERMINED ON THE FRAGMENTS OF THE LINER. THE MEASURED AVERAGE RELATIVE BULK DENSITY COMPLIES WITH THE DELIVERY SPECIFICATION FOR BIOLOX DELTA COMPONENTS (= 99%). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALTHOUGH THE LINER FAILURE CANNOT BE TRACED TO DESIGN OR MANUFACTURING, A DEFINITE ROOT CAUSE CANNOT BE ESTABLISHED DUE TO THERE BEING MULTIPLE FACTORS. CONSIDERATION MUST BE GIVEN TO ALL POTENTIAL INFLUENCES SUCH AS SURGICAL PROCESS, PATIENT VARIABLES (E.G. ACTIVITY LEVEL AND USE), ANATOMICAL CONSIDERATIONS AND PATIENT CHANGES OVER TIME. ANY CONCLUSIONS FROM THE INVESTIGATIONAL INPUT PROVIDED HAVE TO BE PLACED INTO CONTEXT WITH ALL OTHER RELEVANT FACTORS. IT IS HIGHLY RECOMMENDED TO THE PATIENT TO CONSULT WITH THEIR HEALTHCARE PROFESSIONAL FOR FURTHER ASSESSMENT. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE DELTA CER INSERT 32ID X 50OD WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: PROTOCOLS AND ACCEPTANCE CERTIFICATE WERE REVIEWED. THE QUALITY DOCUMENTS SHOWS THAT THE DATA OBTAINED ON THE CERAMIC LINER CONFORMED TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFIL REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE IS NO INDICATION OF ANY PRE-EXISTING MATERIAL DEFECT. QUANTITY MANUFACTURED: 15. DATE OF MANUFACTURE: 10-JAN-2023. ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NONE. EXPIRY DATE: 12-2027. IFU REFERENCE: (B)(4). DEVICE HISTORY BATCH: NULL DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [121882750 / 4029764] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING. H11 ADDITIONAL NARRATIVE: CORRECTED: H3.
PRODUCT COMPLAINT #(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: CORRECTED: H6 (HEALTH EFFECT - IMPACT CODE). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED THAT A FRACTURED CERAMIC HIP COMPONENT LEFT SIDE. DOI: (B)(6) 2024 DOE: (B)(6) 2024 AFFECTED SIDE: LEFT.
ADDITIONAL INFORMATION RECEIVED: 1. INDICATION FOR IMPLANTATION. COXARTHROSIS LEFT, Z.N. HIP TEP RE 2020, HERE SYMPTOM-FREE, CLINICAL PAIN AND RESTRICTION OF MOVEMENT, RADIOLOGICAL COXARTHROSIS STAD 4 ACCORDING TO KELLGREN AND LAWRENCE 2. IMPLANTATION/REVISION DATE, IF NECESSARY PLANNED REVISION DATE IMPLANTATION (B)(6) 2024 REVISION: (B)(6) 2024. 3. SEE ABOVE, ADDITIONALLY, ANEURYSM COILING LEFT AT SAB. 4. WHICH COMPONENTS WERE REMOVED DURING THE REVISION OPERATION? WHICH COMPONENTS WERE USED FOR THE NEW SUPPLY? WE ASK YOU FOR PRECISE INFORMATION ABOUT THE MANUFACTURER AND TRADE NAME OF THE MEDICAL DEVICES, THE CATALOG NUMBER, THE BATCH NUMBER: REMOVED: INLAY CERAMIC CERAMAX, SIZE 50 HEAD SIZE 32MM LOT: 4029764 REF: (B)(4). MANUFACTURER: DEPUYSYNTHES. HIP HEAD, CERAMIC HEAD 32MM NECK LENGTH +1MM (S) LOT: 4274517 REF: (B)(4) MANUFACTURER: DEPUYSYNTHES. RE-SUPPLY: INLAY MARATHON PE-INLAY NEUTRAL SIZE 50 HEAD SIZE 28MM LOT: M2590N REF: (B)(4) MANUFACTURER: DEPUYSYNTHES. BIOBALL ADAPTER 12/14 STANDARD S (-3.0) LOT: MS2015884 REF: (B)(4). MANUFACTURER: MERETE GMBH BIOBALL DELTA 12/14 PLUG-IN HEAD 28MM LOT: 7011881893/11 REF: (B)(4). MANUFACTURER: MERETE GMBH 5. WHERE ARE THE EXPORTED PRODUCTS LOCATED, OR WHO CARRIES OUT THE MATERIAL-TECHNICAL EXAMINATION? THE MANUFACTURER: DEPUYSYNTHES HAS REQUESTED THE EXPORTED PRODUCTS. 6. ARE THE EXPORTED COMPONENTS AVAILABLE TO THE MANUFACTURER FOR EXAMINATION, IF ANY, THE TEST RESULTS/X-RAYS/SURGICAL REPORTS/PHOTOS OF THE PRODUCT CONCERNED? EVERYTHING THAT IS REQUESTED IS ALLOWED BY THE AFFECTED PATIENT. 7. NUMBER OF COMPARABLE INCIDENTS: 1 CASE IN 2023
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 664127 | DELTA CER INSERT 32ID X 50OD | HIP CERAMIC ACETABULAR LINERS | MRA | DEPUY ORTHOPAEDICS INC US | 4029764 | 10603295423263 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention | DELTA CER HEAD 12/14 32MM +1. |