HIP BALL BIOLOX 32 +5 12/14
Report
- Report Number
- 1818910-2022-20209
- Event Type
- Injury
- Date Received
- October 12, 2022
- Date of Event
- August 25, 2022
- Report Date
- October 12, 2022
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- LPH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, 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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : THE DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. VISUAL ANALYSIS OF THE PROVIDED PHOTOGRAPHIC EVIDENCE ALONG WITH PHYSICAL EXAMINATION OF THE DEVICE DENOTED A WORN APPEARANCE AT THE PART. IT WAS POSSIBLE TO IDENTIFY A DISASSOCIATION EVENT AMONG CUP AND LINER SINCE IT WAS FOUND THAT OCCURRED A TRANSFER OF THE TITANIUM CUP MATERIAL ONTO THE SURFACE OF THE CERAMIC HEAD. IT IS SUBSEQUENT THE LINER DISASSOCIATION AND DOES NOT SIGNIFY ANY PRODUCT ERROR. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : BFARM DHR REVIEW REQUEST: PRODUCT DESCRIPTION: HIP BALL BIOLOX 32 +5 12/14 PRODUCT CODE: 9111132 LOT NUMBER: 3408941. 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 01/10/2012 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NONE. NO NON CONFORMANCES WERE IDENTIFIED. 4) EXPIRY DATE: 01/2017 5) IFU REFERENCE: 902-00-701. DEVICE HISTORY REVIEW : A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (9111132/3408941) PRODUCT AND LOT NUMBERS, AND NO NON-CONFORMANCES WERE IDENTIFIED.
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : THE DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. VISUAL ANALYSIS OF THE PROVIDED PHOTOGRAPHIC EVIDENCE ALONG WITH PHYSICAL EXAMINATION OF THE DEVICE DENOTED A WORN APPEARANCE AT THE PART. IT WAS POSSIBLE TO IDENTIFY A DISASSOCIATION EVENT AMONG CUP AND LINER SINCE IT WAS FOUND THAT OCCURRED A TRANSFER OF THE TITANIUM CUP MATERIAL ONTO THE SURFACE OF THE CERAMIC HEAD. IT IS SUBSEQUENT THE LINER DISASSOCIATION AND DOES NOT SIGNIFY ANY PRODUCT ERROR. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : BFARM DHR REVIEW REQUEST: PRODUCT DESCRIPTION: HIP BALL BIOLOX 32 +5 12/14 PRODUCT CODE: 9111132 LOT NUMBER: 3408941. 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 01/10/2012 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NONE. NO NON CONFORMANCES WERE IDENTIFIED. 4) EXPIRY DATE: 01/2017 5) IFU REFERENCE: 902-00-701. DEVICE HISTORY REVIEW : A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (9111132/3408941) PRODUCT AND LOT NUMBERS, AND NO NON-CONFORMANCES WERE IDENTIFIED.
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. (THE CONCOMITANT PRODUCTS WERE UPDATED FORM UNKNOWN TO KNOWN PRODUCTS).
REVISION OF ACETABULAR COMPONENTS OF A HIP-TEP. DOI: UNKNOWN, DOR: (B)(6) 2022, UNKNOWN SIDE.
ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY ADVERSE CONSEQUENCE/S TO THE PATIENT THAT LED TO THE REVISION SURGERY? YES, PAIN WHEN BENDING. B. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. C. WHAT IS THE AFFECTED SIDE? RIGHT SIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2744768 | HIP BALL BIOLOX 32 +5 12/14 | ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS | LPH | DEPUY ORTHOPAEDICS INC US | 3408941 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female | Required Intervention | APEX HOLE ELIM POSITIVE STOP| CORAIL2 STD SIZE 9| PINN MAR +4 NEUT 32IDX50OD| PINNACLE SECTOR II CUP 50MM| UNK HIP ACETABULAR AUGMENT| UNK HIP ACETABULAR LINER POLY| UNKNOWN HIP ACETABULAR CUP |