MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 48MM O.D. SIZE GG POROUS UNCEMENTED WITH CLUSTER HOLES SHELL USE WITH GG LINERS; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	12/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by legal that a patient had an initial left total hip arthroplasty performed.Subsequently, the patient has reported ongoing pain and decreased quality of life since the implantation.Patients relay fear of not being able to walk unaided in the future.No further information has been given.
Additional Manufacturer Narrative
(b)(4).D10: 00811400010 femoral stem 12/14 neck taper ext.Offset size 0 105 mm stem length 65885695.00875200832 32mm i.D.Size gg elevated rim liner use with 48mm o.D.Size gg shell 66043601.G2: foreign: united kingdom.The 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.
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, 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 related to the reported event.Medical records were not provided in relation to this reported event.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 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 information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11 the reported event could not be confirmed due to lack of product/information.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 provided only confirm that a left total hip replacement is in situ.Additional records relating to the left side were not provided.A definitive root cause cannot be determined.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.

• Brand Name: 48MM O.D. SIZE GG POROUS UNCEMENTED WITH CLUSTER HOLES SHELL USE WITH GG LINERS
• Common Device Name: PROSTHESIS, HIPS
• 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: 22020778
• Report Number: 0001822565-2025-01380
• Device Sequence Number: 21027462
• Product Code: LPH
• UDI-Device Identifier: 00889024151314
• UDI-Public: (01)00889024151314(17)330722(10)66057871
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K151448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2026

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 Model Number: N/A
• Device Catalogue Number: 00875704801
• Device Lot Number: 66057871
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 07/16/2025; 04/08/2026
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 08/05/2025; 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2023
• 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: Other
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 104 KG