MAUDE Adverse Event Report: BIOMET UK LTD. HAP MODULAR TAPERLOC FML 13.5X147; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER

Catalog Number	21-123207
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 ¿ 650-1058, cer bioloxd option hd 40mm, lot 1941726.650-0798, biolox delta lnr 40mm 58-60mm, lot 2063944.650-1066, cer opt type 1 tpr sleve 0mm, lot 2240861.124858ha, exc abt std shell ha/pc 058mm, lot 2125841.G2 ¿ foreign ¿ australia.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 3500a will be submitted.
Event or Problem Description
It was reported that the patient underwent hip revision surgery approximately thirteen and a half years post implantation.The patient had an early dislocation and then after reduction, the hip has survived without dislocation until recently.As there have been a number of dislocations, the decision was made to revise the cup (version was felt to be not optimal).On opening the hip, both components appeared well fixed.The head was removed but the sleeve remained attached to the femoral steeper.The surgeon attempted to remove this but failed and a decision was made to remove the stem to allow for a new freedom head to be placed.All components were removed.An oseoti shell planted with 3 screws and a freedom liner.An arcos stem was implanted with a freedom head.Hip appeared significantly more stable when testing at the end of the procedure.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h10, h11.The following section was corrected: g4 - pma/510(k) number.The reported event could not be confirmed due to lack of product/information.No product was returned or pictures provided; a product evaluation could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Medical records were not provided.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint histories found no additional related complaints for the cup, the stem, the bearing and the sleeve items and the reported part and lot combinations.Review of the complaint history identified additional similar complaints for the reported head item and no additional similar complaints for the reported part and lot combination.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 further event information available at the time of this report.

• Brand Name: HAP MODULAR TAPERLOC FML 13.5X147
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22861587
• Report Number: 3002806535-2025-00403
• Device Sequence Number: 12700394
• Product Code: LPH
• UDI-Device Identifier: 00880304282230
• UDI-Public: (01)00880304282230(17)200930(10)185550
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 21-123207
• Device Lot Number: 185550
• 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: 07/30/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2010
• 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 Sex: Unknown