MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM I.D. SIZE F HIGH WALL LINER; PROSTHESIS, HIP

Catalog Number	20123606
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Unequal Limb Length (4534)
Date of Event	06/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient received a cortisone injection approximately one year post implantation due to trochanteric bursitis.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D10: cat #: 110010265 / g7 osseoti multihole 54mm f / lot #: 65334975.Cat #: 00625006535 / bone screw self-tapping 6.5 mm dia.35 mm length / lot #: j7302489.Cat #: 00625006530 / bone screw self-tapping 6.5 mm dia.30 mm length / lot #: j7306391.Cat #: 00786401320 / femoral stem press-fit collarless 12/14 neck taper standard body extended neck offset size 13 138 mm stem length cementless / lot #: 65552119.Cat #: 00877503602 / biolox⮠delta, ceramic femoral head, m, 㸠36/0, taper 12/14 / lot #: 3052557.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-02831, 0001822565-2024-02392, 0001822565-2024-03793, 0001822565-2024-03795.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
It was reported that a patient received a cortisone injection to his left hip approximately thirteen months post implantation due to trochanteric bursitis.
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.Updated: d4, g3, g6, h2, h3, h4, h6 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.Chs was not performed for the liner and screws as the reported event is not device related.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left tha was performed, and the patient was diagnosed with trochanteric bursitis and received a cortisone injection.The patient has a leg length discrepancy and wears a shoe lift to compensate, with noted pain as well.No abnormal findings on the x-ray.Images assessed but not sent to mmi as the physicians provides sufficient dictation of the complication.A definitive root cause cannot be determined for the stem in relation to the limb length discrepancy and pain.No problem was found with the devices in relation to the trochanteric bursitis after review by a hcp.This complaint was confirmed based on the provided 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: b5, g3, g6, h2, h11.Chs was not performed for the liner and screws as the reported event is not device related.Additional medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient continues to have recurrence of the trochanteric bursitis, resulting in cortisone injections.A definitive root cause cannot be determined for the stem in relation to the limb length discrepancy and pain.No problem was found with the devices in relation to the trochanteric bursitis after review by an hcp.This complaint was confirmed based on the medical records 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.
Event or Problem Description
It was reported that the patient underwent an initial left total hip arthroplasty.Subsequently, the patient was diagnosed with trochanteric bursitis and received a left hip cortisone injection.At 3 years post-op the patient continues to experience episodes of bursitis; all initial components remain implanted and further details have not been provided at this time.

• Brand Name: 36MM I.D. SIZE F HIGH WALL LINER
• 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: 20833336
• Report Number: 0001822565-2024-03794
• Device Sequence Number: 3598841
• Product Code: LPH
• UDI-Device Identifier: 00889024519336
• UDI-Public: (01)00889024519336(17)270717(10)65516813
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/27/2025

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 Catalogue Number: 20123606
• Device Lot Number: 65516813
• 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: 11/11/2024
• Supplement Date Received by Manufacturer: 12/03/2024; 03/24/2025; 08/01/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 12/30/2024; 03/31/2025; 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 108 KG
• Patient Race: White