MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM I.D. SIZE E NEUTRAL LINER; PROSTHESIS, HIP

Catalog Number	20103605
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 2 and a half years post implantation, the patient was given a depo-medrol injection as well as prescribed medrol doepak 4mg tablets due to greater trochanter pain as well as bilateral knee pain.There is no further information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10: (b)(6), item name: femoral stem cementless collared high offset 12/14 taper size 3 lot #: 3074345.(b)(6), item name: g7 pps ltd acet shell 52e, lot #: 7127194.(b)(6), item name: bioloxâ® delta, ceramic femoral head, m, 㸠36/0, taper 12/14, lot #: 3090848.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that 2 and a half years post implantation, the patient was given a depo-medrol injection as well as prescribed medrol doepak 4mg tablets due to greater trochanter pain as well as bilateral knee pain.There is no further information available at the time of this report.
Event or Problem Description
There is no update to the prior event description provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4 g3 g6 h2 h6 h11.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: greater trochanter pain and bilateral knee pain.Steroid injection given as well as medrol doepak.At follow-up: patient reports no problems with adl¿s, no pain.Leg lengths equal, no limp noted.Radiographs were not sent to mmi as sending the images would not enhance the investigation.A definitive root cause cannot be determined.The complaint is confirmed based on the medical record findings.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.

• Brand Name: 36MM I.D. SIZE E NEUTRAL 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: 21787162
• Report Number: 0001822565-2025-00916
• Device Sequence Number: 12914291
• Product Code: LPH
• UDI-Device Identifier: 00889024518742
• UDI-Public: (01)00889024518742(17)270111(10)65255951
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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: Lay User/Patient
• Device Catalogue Number: 20103605
• Device Lot Number: 65255951
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE H11.; PLEASE SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White