UNKNOWN TM BASEPLATE 25MM
Report
- Report Number
- 0001825034-2025-02225
- Event Type
- Injury
- Date Received
- July 24, 2025
- Date of Event
- May 30, 2018
- Report Date
- October 2, 2025
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- PHX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4) THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D1; D2; D5; D10; G2; G3; G6; H1; H2. D10: MEDICAL PRODUCTS: ITEM#: 211215, COMPR SRS PROX BDY - SM 48MM; LOT#: 965930, ITEM#: 211238, COMPR SRS MOD STEM - 12X100MM; LOT#: 092190, ITEM#: 115375, COMP RVS TRAY +5MM CO 44MM; LOT#: 637540, ITEM#: EP-115393, E1 44-36 STD HMRL BRNG; LOT#: 256980 , ITEM#: 211228, COMPR SRS MOD RGX AUG - SM; LOT#: 072300. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
(B)(4). D10: MEDICAL PRODUCTS: ITEM#: 211215, COMPR SRS PROX BDY - SM 48MM; LOT#: 965930. ITEM#: 211238, COMPR SRS MOD STEM - 12X100MM; LOT#: 092190. ITEM#: 115375, COMP RVS TRAY +5MM CO 44MM; LOT#: 637540. ITEM#: EP-115393, E1 44-36 STD HMRL BRNG; LOT#: 256980. ITEM#: 211228, COMPR SRS MOD RGX AUG - SM; LOT#: 072300. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G2; G3; G6; H1; H2; H3; H6. PRODUCT HAS NOT BEEN RETURNED. NO PRODUCT EVALUATION WAS ABLE TO BE COMPLETED. ROOT CAUSE OF THE REPORTED EVENT IS NOT DEVICE RELATED. CELLULITIS IS A RAPID-SPREADING BACTERIAL INFECTION OF THE DERMIS AND SUBCUTANEOUS TISSUES, OFTEN CAUSED BY NORMAL SKIN FLORA OR OPPORTUNISTIC RESIDENTIAL BACTERIA, SUCH AS STREPTOCOCCUS PATHOGENS. CELLULITIS APPEARS AS LOCALIZED REDNESS, SWELLING, AND RASH THAT IS HOT AND PAINFUL TO TOUCH. THE BACTERIA ENTER THE SKIN VIA ANY CUT, ABRASION, OR BREAK IN THE SKIN, THUS PLACING POSTOPERATIVE JOINT PATIENTS AT INCREASED RISK FOR THE DEVELOPMENT OF CELLULITIS. OTHER COMORBIDITIES THAT INCREASE THE RISK FOR POST OPERATIVE DEVELOPMENT OF CELLULITIS INCLUDE SMOKING, DIABETES, POOR NUTRITION, OBESITY, POOR HYGIENE, OR CIRCULATORY PROBLEMS. CELLULITIS MAY RESOLVE ON ITS OWN WITH CONSERVATIVE TREATMENT BUT MOST OFTEN REQUIRES ADDITIONAL MEDICAL INTERVENTION, SUCH AS ORAL OR INTRAVENOUS ANTIBIOTICS, TO ERADICATE THE INFECTION. 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.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY SEVEN (7) YEARS AND THREE MONTHS AGO WHERE A MANIPULATION WITH LYSIS OF ADHESION AND ROTATOR CUFF REPAIR DUE TO LIMITED RANGE OF MOTION AND PERSISTENT PAIN WAS PERFORMED. SUBSEQUENTLY, THE PATIENT APPROXIMATELY A MONTH AFTER THE REVISION SURGERY WAS DIAGNOSED WITH CELLULITIS AND WAS PRESCRIBED ANTIBIOTICS. THE CELLULITIS WAS RESOLVED APPROXIMATELY TWO (2) MONTHS LATER.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2127326 | UNKNOWN TM BASEPLATE 25MM | SHOULDER IMPLANT/EXTREMITIES | PHX | ZIMMER BIOMET, INC. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Female | Required Intervention| O | SEE H11 NARRATIVE| SEE H11 NARRATIVE |