METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 50 44, CODE J
Report
- Report Number
- 0009613350-2019-00022
- Event Type
- Injury
- Date Received
- January 11, 2019
- Report Date
- September 9, 2020
- Manufacturer
- ZIMMER 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
- BE
- Reporter Occupation
- 003
Narratives
ADDITIONAL INFORMATION WHICH WAS RECEIVED ON (B)(6) 2020. D11- MEDICAL PRODUCTS: METASUL LDH, HEAD, 44, CODE J, TAPER 18/20; ITEM#: 01.00181.440; LOT#: 2477578 AVENIR MUELLER, STEM, STANDARD, UNCEMENTED; ITEM#: 01.06010.004; LOT#: 4012523. THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. CORRECTION: B5, E1, E2, E3, G3. ADDITIONALS: D4, G4, G7, H1, H2, H3, H4, H10. THE MANUFACTURER RECEIVED X-RAYS AND OTHER SOURCE DOCUMENTS WHICH WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE OR AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF INITIAL MEDWATCH. ADDITIONAL INFORMATION: PATIENT NAME : A. E. PATIENT DATE OF BIRTH : JUNE 07, 1993. CHANGED FIELDS: NEW INFORMATION DOES NOT CHANGE THE INVESTIGATION-RESULTS OF THIS INCIDENT, A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF INITIAL MEDWATCH. NEW INFORMATION RECEIVED: DEVICE REF. NUMBERS. IMPLANT DATE. EXPLANT DATE. CONCOMITANT MEDICAL PRODUCTS ACCORDING D11: NAME: METASUL LDH, HEAD, 44, CODE J, TAPER 18/20 ITEM#: 01.00181.440 LOT#: UNKNOWN. NAME: METASUL LDH, HEAD ADAPTER, M, 0, TAPER 12/14-18/20 ITEM#: 01.00185.146 LOT#: UNKNOWN. NAME: AVENIR MUELLER, STEM, STANDARD, UNCEMENTED ITEM#: 01.06010.004 LOT#: UNKNOWN. NEW INFORMATION DOES NOT CHANGE THE INVESTIGATION-RESULTS OF THIS INCIDENT, A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
ADDITIONAL INFORMATION WHICH WAS RECEIVED ON AUG 14, 2020. D11: MEDICAL PRODUCT: METASUL LDH, HEAD ADAPTER, M, 0, TAPER 12/14-18/20; ITEM#: 0100185146; LOT#: 2481873. THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. THE MANUFACTURER RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE OR AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF INITIAL MEDWATCH. CORRECT DOB : (B)(6) 1933. IMPLANT SIDE: RIGHT. OTHER REASONS FOR REVISION: FLUID COLLECTION, FIBROSE AND CUP WAS NOT FIXED WELL. ALSO, PATIENT FELL ON THE STAIRS. NEW INFORMATION DOES NOT CHANGE THE INVESTIGATION-RESULTS OF THIS INCIDENT, A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
PATIENT WAS IMPLANTED ON AN RIGHT SIDE AND UNDERWENT REVISION SURGERY DUE TO PAIN, ELEVATED METAL ION LEVELS, PSEUDOTUMOR AND FLUID COLLECTION.
NO NEW INFORMATION AVAILABLE.
IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH METASUL DUROM, COMPONENT. SUBSEQUENTLY, THE PATIENT WENT TO REVISION SURGERY DUE TO ELEVATED ION LEVELS, PSEUDOTUMOR AND PAIN.
PATIENT WAS IMPLANTED ON AN RIGHT SIDE AND UNDERWENT REVISION SURGERY DUE TO PAIN, ELEVATED METAL ION LEVELS, PSEUDOTUMOR AND FLUID COLLECTION.
IT WAS NOW THE FOLLOWING REPORTED: OTHER REASONS FOR REVISION: FLUID COLLECTION, FIBROSE AND CUP WAS NOT FIXED WELL. ALSO, PATIENT FELL ON THE STAIRS.
CONCOMITANT MEDICAL PRODUCTS: METASUL LDH, HEAD, 38, CODE D, TAPER 18/20; CATALOG NO#: 01.00181.380 ; LOT#: UNKNOWN, THERAPY DATE: UNKNOWN. THE MANUFACTURER DID NOT RECEIVE DEVICES OR X-RAYS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. BASED ON AN EXTENSIVE INVESTIGATION OF EVENTS REPORTED FROM SEVERAL USER FACILITIES OUTSIDE THE USA, ZIMMER IDENTIFIED THAT THE MOST PROBABLE CAUSE FOR THE OUTCOME OBSERVED WAS A LOOSE OR UNSTABLE CUP THAT RESULTED FROM USE OF SURGICAL TECHNIQUES NOT CONSISTENT WITH THE MANUFACTURER'S RECOMMENDATIONS. AS A CORRECTIVE ACTION, A RETRAINING PROGRAM FOR USERS OUTSIDE THE USA WAS INITIATED IN NOVEMBER 2009 AND REPORTED TO THE NATIONAL COMPETENT AUTHORITIES AS REQUIRED. THE DUROM CUP REPORTED IN THIS CASE IS NOT MARKETED IN THE USA. A SIMILAR CUP, COMPATIBLE WITH THE METASUL LDH FEMORAL HEAD, IS CLEARED IN THE USA AND A CORRECTIVE ACTION FOR THIS PRODUCT WAS REPORTED TO THE FDA IN JULY 2008 AS NOTIFICATION Z-2415/2426-2008. SINCE THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTIVE ACTION THERE WILL BE NO FURTHER INVESTIGATION. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE AND UNDERWENT REVISION SURGERY DUE TO PAIN, ELEVATED METAL ION LEVELS, PSEUDOTUMOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 32708 | METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 50 44, CODE J | UNKNOWN | KWA | ZIMMER GMBH | N/A | 2477601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |