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 Material Erosion (1214); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Necrosis (1971); Pain (1994); Osteolysis (2377); Muscle/Tendon Damage (4532); Insufficient Information (4580)

Event Date 07/22/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: 00771100910 femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 9 standard offset reduced neck length 63766104.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2024 - 00673.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 the patient underwent an initial right hip arthroplasty.Subsequently, the patient was revised three (3) years post implantation for unknown reasons.

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.An adequate complaint history review cannot be performed as the complication, failure mode, and/or harm experienced by the user is unknown.Medical records were not provided.A definitive root cause cannot be determined.This complaint cannot be confirmed.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

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.

Event Description

It was reported that a patient had an initial right total hip arthroplasty.Subsequently, the patient was revised due to pain and elevated chromium levels.During the revision, necrotic and avascular tissue consistent with trunnionosis was debrided from the joint space.The stem was cleared of black metal debris, and a new head and liner were placed while the initial stem and shell remained intact.Over time the patient¿s serum metal ion levels returned to normal levels.

• 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: 18790482
• MDR Text Key: 336355263
• Report Number: 0002648920-2024-00053
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024144675
• UDI-Public: (01)00889024144675(17)280630(10)64088532
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953337
• 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
• 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 Model Number: N/A
• Device Catalogue Number: 00801803202
• Device Lot Number: 64088532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 03/06/2024; 04/25/2024
• Supplement Dates FDA Received: 03/07/2024; 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2018
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female