COMP LK SCR 3.5HEX 4.75X25 ST
Report
- Report Number
- 0001825034-2021-03371
- Event Type
- Injury
- Date Received
- December 20, 2021
- Date of Event
- December 9, 2021
- Report Date
- April 14, 2022
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- KWS
- UDI-DI
- 00880304677159
- PMA / PMN Number
- K132239
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). (B)(6). CONCOMITANT MEDICAL PRODUCT: CATALOG #: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR, LOT # 945930, CATALOG #: UNKNOWN, UNKNOWN STEM, LOT # UNKNOWN, CATALOG #: 115398, COMP RVS CNTRL 6.5X40MM ST/RST, LOT # 355980, CATALOG #: 180553, COMP LK SCR 3.5HEX 4.75X30 ST, LOT # 699640, CATALOG #: 115316, COMP RVRS SHLDR GLNSP +6 36MM, LOT # 171330, CATALOG #: 115370, COMP RVS TRAY CO 44MM, LOT # 452990, CATALOG #: XL-115364, ARCOM XL 44-36 STD +3 HMRL BRG, LOT # 875670. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-03368, 0001825034-2021-03369, 0001825034-2021-03370, 0001825034-2021-03372.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DURING THE INVESTIGATION PROCESS FOR INFECTION A REVIEW OF THE STERILE CERTIFICATIONS WERE REVIEWED AND FOUND TO BE CONFORMING WITH NO APPLICABLE DEVIATIONS. DEVICES WERE VERIFIED TO HAVE GONE THROUGH ACCEPTABLE STERILIZATION PROCESS FOLLOWING ISO/AAMI/ASTM & EU PUBLISHED GUIDELINES. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E. HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUES IDENTIFIED AFFECTING IMPLANT SAFETY OR EFFECTIVENESS, THEREFORE IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: LEFT TOTAL SHOULDER ARTHROPLASTY WITH MALPOSITION OF THE GLENOSPHERE DIRECTED SUPERIORLY AND INFERIOR SUBLUXATION OF THE HUMERAL COMPONENT. NO SIGNS OF LOOSENING, WEAR, RADIOLUCENCY. HOWEVER, IT IS UNKNOWN WHEN THIS X-RAY WAS TAKEN. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4) MANUFACTURE OFFICE: (B)(6). CONCOMITANT MEDICAL PRODUCT: CATALOG #: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR, LOT # 945930, CATALOG #: UNKNOWN, UNKNOWN STEM, LOT # UNKNOWN, CATALOG #: 115398, COMP RVS CNTRL 6.5X40MM ST/RST, LOT # 355980, CATALOG #: 180553, COMP LK SCR 3.5HEX 4.75X30 ST, LOT # 699640, CATALOG #: 115316, COMP RVRS SHLDR GLNSP +6 36MM, LOT # 171330, CATALOG #: 115370, COMP RVS TRAY CO 44MM, LOT # 452990, CATALOG #: XL-115364, ARCOM XL 44-36 STD +3 HMRL BRG, LOT # 875670. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-03368, 0001825034-2021-03369, 0001825034-2021-03370, 0001825034-2021-03372.
IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 8 MONTHS POST-IMPLANTATION DUE TO LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 8 MONTHS POST-IMPLANTATION DUE TO LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1941890 | COMP LK SCR 3.5HEX 4.75X25 ST | FIXATION, FASTENER | KWS | ZIMMER BIOMET, INC. | N/A | 265360 | 00880304677159 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention| H | SEE H10 |