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

Model Number	N/A
Medical Device Problem Codes	Material Erosion (1214); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Necrosis (1971); Pain (1994); Osteolysis (2377); Muscle/Tendon Damage (4532); Insufficient Information (4580); High metal ion levels (4847)
Date of Event	07/22/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.
Event or Problem 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Proposed component code: mechanical (g04)- head.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial hip arthroplasty occurred.Subsequently, a revision occurred due to pain, trunnionosis, and elevated cobalt levels.Metal debris was found on the trunnion but fairly minimal evidence on the inside of the metal head.Trunnion wear debrided from the stem.New head/liner placed.Serum cobalt and chromium levels were normal; root cause is unchanged.The complaint is confirmed based on the medical records.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 or Problem Description
No additional event information to report at this time.

• Brand Name: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
• Common Device Name: 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
• Report Number: 0002648920-2024-00053
• Device Sequence Number: 12720883
• Product Code: LPH
• UDI-Device Identifier: 00889024144675
• UDI-Public: (01)00889024144675(17)280630(10)64088532
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/09/2024

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 03/06/2024; 04/25/2024; 08/08/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 03/07/2024; 05/16/2024; 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female