ANATOMICAL SHOULDER¿¢, GLENOID, PEGGED, CEMENTED, M
Report
- Report Number
- 0009613350-2025-00060
- Event Type
- Injury
- Date Received
- February 18, 2025
- Report Date
- May 22, 2025
- Manufacturer
- ZIMMER GMBH
- Product Code
- HSD
- UDI-DI
- 00889024285859
- PMA / PMN Number
- K193099
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). D10: ITEM # 0104212465, ANATOMICAL SHOULDER¿¢ DOMELOCK®, HUMERAL HEAD, ø 46-16, R=26.1MM, LOT # 2889557. ITEM # 0104227005, ANATOMICAL SHOULDER¿¢ DOMELOCK®, DOME, CENTRIC, LOT # 2885048. ITEM # 0104201123, ANATOMICAL SHOULDER¿¢, HUMERAL STEM, UNCEMENTED, ø 12, 100 MM, LOT # 2928554. 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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H10, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS AND THE PART AND LOT COMBINATIONS. IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, AT THE FOLLOW-UP, RADIOGRAPHIC IMAGING DISPLAYED OSTEOLYSIS, HETEROTOPIC OSSIFICATION, AND SUBSIDENCE. DURING THE SPRING, THE PATIENT UNDERWENT A TOOTH EXTRACTION PROCEDURE AND DEVELOPED AND UNDERWENT TREATMENT FOR SEPSIS IN. THE PATIENT DEVELOPED SEVERE PAIN WHICH RESOLVED IN THE AUTUMN OF THE SAME YEAR. ALL IMPLANTS REMAIN IN PLACE. BASED ON THE AVAILABLE INFORMATION, THE REPORTED OF OSTEOLYSIS AND SUBSIDENCE EVENT CAN BE CONFIRMED, BUT A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. DURING THE INVESTIGATION PROCESS 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, IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION. AS TIMEFRAMES FOR ONSET OF HETEROTOPIC OSSIFICATION DIFFER DUE TO INDIVIDUAL CONTRIBUTING FACTORS, A SPECIFIC TIMEFRAME OF EXPECTED OCCURRENCE CANNOT BE ESTABLISHED. 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). D10: ITEM # 0104212465, ANATOMICAL SHOULDER¿¢ DOMELOCK®, HUMERAL HEAD, ø 46-16, R=26.1MM, LOT # 2889557 ITEM # 0104227005, ANATOMICAL SHOULDER¿¢ DOMELOCK®, DOME, CENTRIC, LOT # 2685048 ITEM # 0104201123, ANATOMICAL SHOULDER¿¢, HUMERAL STEM, UNCEMENTED, ø 12, 100 MM, LOT # 2928554 G2: REPORT SOURCE SWITZERLAND THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY ON. SUBSEQUENTLY, AT THE TWO YEARS FOLLOW UP, RADIOGRAPHIC IMAGING DISPLAYED OSTEOLYSIS, HETEROTOPIC OSSIFICATION, AND SUBSIDENCE. AFTER APPROXIMATELY 5 YEARS POST IMPLANTATION, THE PATIENT UNDERWENT A TOOTH EXTRACTION PROCEDURE AND DEVELOPED AND UNDERWENT TREATMENT FOR SEPSIS. SUBSEQUENTLY, APPROXIMATELY 6 YEARS AND 4 MONTHS POST IMPLANTATION THE PATIENT DEVELOPED SEVERE PAIN WHICH RESOLVED IN THE AUTUMN OF THE SAME YEAR. ALL IMPLANTS REMAIN IN PLACE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1638879 | ANATOMICAL SHOULDER¿¢, GLENOID, PEGGED, CEMENTED, M | PROSTHESIS, SHOULDER | HSD | ZIMMER GMBH | 2898389 | 00889024285859 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Female | Other | SEE H11 NARRATIVE.| SEE H11 NARRATIVE. |