MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZMR HIP SYSTEM NUT COMPRESSION; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Numbness (2415)
Date of Event	04/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 00877504003, lot# 2965104, biolox⮠delta, ceramic femoral head, l, 㸠40/+3.5, taper 12/14; cat# unk, lot# ljr382, unk, stryker cup.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.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 that approximately three years post-implantation, the patient reports ongoing right hip pain and numbness from hip to foot.Another revision is being planned but it is unknown if a revision has been scheduled to date.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h3; h6; h10.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 for the body and nut.Medical records were not provided.Available information was reviewed by a health care professional and identified the following: the patient has underwent many revisions since his initial surgery, the most recent being a revision where the construct was explanted and new devices placed as a spacer for infection following a fall.The patient reports feeling pain and numbness from hip to foot.The spacer is still in situ.A revision has not been scheduled to date.A definitive root cause cannot be determined for the pain and peripheral nerve damage.User error and off label use was identified, as the patient still has their spacer in situ from the previous revision for infection.Per ifu for the head, it states an active infection is a contraindication of the product.This complaint cannot be confirmed.Medical records were not provided in relation to this event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b2; b3; b5; b7; g3; h2; h6.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 that approximately four years post-implantation, the patient underwent a second stage hip revision following ongoing right hip pain and numbness from hip to foot.Loosening of the competitor acetabular cup was found during the procedure.All implants except the stem were revised without complication.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: a revision occurred for pain and loosening of the competitor cup.During the revision, there were no signs of infection and the samples were negative.Tissues were identified to be deficient and were repaired.All hip implants except for the stem were explanted with no complications noted.Root cause unchanged.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further information is available at the time of this report.

• Brand Name: ZMR HIP SYSTEM NUT COMPRESSION
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19608923
• Report Number: 0001822565-2024-02138
• Device Sequence Number: 12792413
• Product Code: JDI
• UDI-Device Identifier: 00889024160941
• UDI-Public: (01)00889024160941(17)271130(10)63855103
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 11/07/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00998209902
• Device Lot Number: 63855103
• 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: 06/04/2024
• Supplement Date Received by Manufacturer: 10/29/2024; 06/12/2025; 11/04/2025
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 11/01/2024; 07/08/2025; 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2017
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Sex: Male
• Patient Weight: 113 KG