MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER; PROTHESIS, HIPS

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Naturally Worn (2988)

Patient Problems Pain (1994); Synovitis (2094); Metal Related Pathology (4530)

Event Date 11/09/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is unknown which devices were explanted during the revision surgery.743001135 femoral stem 13.5mm 60398395.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00459.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient had an initial left total hip arthroplasty.Subsequently, the patient underwent a first revision surgery two (2) years post implantation due to acetabular loosening; during which, a new metal shell, metal head, and poly liner was placed.Subsequently, the patient had a second revision fourteen (14) years post implantation due to pain, wear, and metallosis.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Updated: d4, d10, g3, g6, h2 d10: 00630505036 liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells 60912574 00620205422 shell porous with cluster holes 54 mm 60868099.

Event Description

No additional event information to report at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Proposed component code: mechanical (g04)- head 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 related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient had an initial left that with no complications noted.The first revision occurred due to cup loosening; no complications were noted.Medical records were not provided for the second revision that occurred; however, it was indicated in the legal claim that a revision occurred to remove the metal-on-metal products within the scope of a recall due to pain, wear, and metallosis.No other information was provided.This complaint cannot be confirmed.Medical records were not provided for the second revision, only the legal claim.A definitive root cause cannot be determined.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.

Event Description

It was reported that the patient underwent a revision procedure 14 years and 4 months post implantation as the patient presented with pain and popping in the hip.Labs revealed an elevated titanium level.During the revision, the poly liner fracture was noted and mechanically-assisted crevice corrosion was found at the head-neck taper.The trunnion was found to have gross metal wear debris, and the acetabular shell was also grossly worn from the metal head.The initial stem remained intact, and all other components were revised without complication.The patient completed inpatient rehabilitation postop without further complications.There is no additional information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

• Brand Name: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
• Type of Device: PROTHESIS, HIPS
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18661931
• MDR Text Key: 334795964
• Report Number: 0002648920-2024-00033
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00801803601
• Device Lot Number: 60884562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 03/22/2024; 04/22/2024; 05/08/2024
• Supplement Dates FDA Received: 04/08/2024; 04/23/2024; 05/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE; SEE H11 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 132 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Native Hawaiian Or Other Pacific Islander