UNKNOWN PPF-05 STEM HIP IMPL WIN GEN
Report
- Report Number
- 0009613350-2022-00547
- Event Type
- Injury
- Date Received
- October 20, 2022
- Date of Event
- September 5, 2022
- Report Date
- January 17, 2023
- Manufacturer
- ZIMMER SWITZERLAND MANUFACTURING GMBH
- Product Code
- KWA
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). FOREIGN: GERMANY. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCT WAS RETURNED TO WINTERTHUR AND PHOTOGRAPHED. REVIEW OF THE PHOTOGRAPHS CONFIRM THAT THE NECK HAS FRACTURED. BONE CEMENT IS PRESENT ON THE STEM. THERE IS NO ITEM AND LOT ETCHING ON THE TOP OF THE TAPER AND THE EMBOSSED LETTERING ON THE SIDE OF THE STEM DOES NOT RELATE TO THAT REQUIRED ON THE AVAILABLE DRAWING. VISUALLY, COMPARING THE DRAWING TO THE COMPONENT, THE NECK AND TAPER ARE NOT THE SAME PROFILES LEADING US TO BELIEVE THAT THE PART IS NOT AS REPORTED AS A ZIMMER BIOMET PPF STEM. FURTHERMORE, THE PRIMARY IMPLANTATION DATE AS REPORTED WAS 1999 WITH THE FIRST DRAWING WHICH COULD BE ESTABLISHED BEING FROM 2006. REVIEW OF THE ASSOCIATED HEAD AND TAPER ADAPTER CONFIRMS ALSO THAT THESE ARE NOT ZIMMER BIOMET DEVICES BUT ARE UNKNOWN BIOBALL PRODUCTS. NO RECORDS COULD BE FOUND FOR THE THE LOT NUMBER WHICH WAS PROVIDED, THEREFORE THIS LEADS US TO BELIEVE THAT THIS ISN¿T A ZIMMER BIOMET PRODUCT AND SUBSEQUENTLY DHR REVIEW COULD NOT BE PERFORMED. DEVICES ARE USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED BECAUSE THERE ARE NO RECORDS THAT THE STEM IS ZIMMER BIOMET'S, FURTHERMORE, THE STEM WAS IMPLANTED WITH A BIOBALL HEAD AND BIOBALL TAPER ADAPTER WHICH ARE ALSO NOT ZIMMER BIOMET PRODUCTS. THIS WHICH ALSO INDICATES THAT THE STEM IS ALSO NOT ZIMMER BIOMET'S.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D1, D4, D9, G3, G6, H1, H2, H3, H10. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
IT WAS REPORTED THAT WHILE WALKING, THE PATIENT FELT A SUDDEN SEVERE PAIN SIMILAR TO A DISLOCATION. PATIENT WAS ADMINISTERED TO THE HOSPITAL. SHAFT / CONE FRACTURE HAS BEEN REPORTED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2820866 | UNKNOWN PPF-05 STEM HIP IMPL WIN GEN | HIP PROSTHESIS | KWA | ZIMMER SWITZERLAND MANUFACTURING GMBH | 97B1537 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Male | Hospitalization| R |