DELTA CER FM HD 036/-4MM 12/14
Report
- Report Number
- 3002806535-2022-00210
- Event Type
- Malfunction
- Date Received
- April 8, 2022
- Date of Event
- April 10, 2021
- Report Date
- July 25, 2022
- Manufacturer
- BIOMET UK LTD.
- Product Code
- LZO
- UDI-DI
- 00887868271342
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- 003
Narratives
(B)(4). INITIAL REPORT. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE PRODUCT HAS BEEN REQUESTED TO BE RETURNED TO ZIMMER BIOMET FOR AN INVESTIGATION. THE INVESTIGATION IS CURRENTLY UNDERWAY. ONCE THE INVESTIGATION HAS CONCLUDED, A FOLLOW-UP MDR WILL BE SUBMITTED.
(B)(4). THIS FOLLOW-UP DOCUMENT IS BEING SUBMITTED TO RELAY SUPPLEMENTAL INFORMATION. SUPPLEMENTAL INFORMATION ACQUIRED: ACTUAL/SUSPECTED PRODUCT DATA. D10 ASSOCIATED PRODUCTS: MEDICAL PRODUCT: G7 HI-WALL E1 LINER 36MM E, CATALOGUE NUMBER: 010000935, LOT NUMBER: 6848102. MEDICAL PRODUCT: G7 OSSEOTI 3 HOLE SHELL 52MM E, CATALOGUE NUMBER: 110010244, LOT NUMBER: 6882116. MEDICAL PRODUCT: TPRLC 133 MP 12/14 BM HO 9.0, CATALOGUE NUMBER: 51-137090, LOT NUMBER: 3975819. THE INVESTIGATION IS CURRENTLY UNDERWAY. ONCE THE INVESTIGATION HAS CONCLUDED, A FOLLOW-UP MDR WILL BE TENDERED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING THAT COULD BE RELATED TO THE REPORTED EVENT. THIS DEVICE IS USED FOR TREATMENT. THE LIKELY CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS CONFORMING TO SPECIFICATION. THE REPORTED EVENT HAS NOT BEEN CONFIRMED AS RELEVANT PHOTOGRAPHS HAVE NOT BEEN PROVIDED AND PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AND THE DHR REVIEW DID NOT IDENTIFY ANY ISSUES. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED, THAT: CLAIM FOR DAMAGES BY THE PATIENT (FEMALE, BORN IN (B)(6)) ALLEGEDLY CAUSED BY PROSTHESIS IMPLANTED ON LEFT HIP ON (B)(6) 2020 AT THE CLINIC ULIVELLA E GLICINI AND FOLLOWED BY REVISION OF THE POLYETHENE INSERT AND CERAMIC HEAD ON (B)(6) 2021. THE CERAMIC HEAD WAS REMOVED AND SHOWED SIGNS OF WEAR FROM CONTACT WITH THE METAL SHELL AND MODEST METALLIC SOFT TISSUE. EXPOSURE TO THE ACETABULUM (G7). THE MOBILIZATION OF THE POLYETHENE (E-POLY) INSERT WAS FOUND TO SHOW COMPLETE RUPTURE OF THE LOCKING MECHANISM WITH NO OTHER SIGNS OF FAILURE.
IT WAS REPORTED, THAT: CLAIM FOR DAMAGES BY THE PATIENT (FEMALE, BORN IN 1966) ALLEGEDLY CAUSED BY PROSTHESIS IMPLANTED ON LEFT HIP ON (B)(6) 2020 AT THE CLINIC ULIVELLA E GLICINI AND FOLLOWED BY REVISION OF THE POLYETHYLENE INSERT AND CERAMIC HEAD ON APRIL 10, 2021. THE CERAMIC HEAD WAS REMOVED AND SHOWED SIGNS OF WEAR FROM CONTACT WITH THE METAL SHELL AND MODEST METALLIC SOFT TISSUE. EXPOSURE TO THE ACETABULUM (G7). THE MOBILIZATION OF THE POLYETHENE (E-POLY) INSERT WAS FOUND TO SHOW COMPLETE RUPTURE OF THE LOCKING MECHANISM WITH NO OTHER SIGNS OF FAILURE.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1072604 | DELTA CER FM HD 036/-4MM 12/14 | BIOLOX DELTA CER FEM HD LG | LZO | BIOMET UK LTD. | N/A | 3033134 | 00887868271342 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Female | SEEH10| SEEH10 |