MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX OPTION TYPE 1 TPR SLEVE +3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number	650-1067
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	02/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 010000857 g7 neutral e1 liner 36mm e 6453164.51-101100 tprlc 133 fp type1 pps ho 10.0 6180882.110017103, g7 finned 3 hole acetabular shell 52e, lot 6401769.650-1057, cer bioloxd option hd 36mm, lot 2958792.00625006525, bone screw self-tapping 6.5 mm dia.25 mm length, lot 64213160.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 six years ago the patient underwent initial right total hip arthroplasty.Four years later the patient presented for an office visit due to severe right inguinal pain.The patient reported she had started pilate's and new exercises.X-rays showed the implants were in satisfactory position without complications.The patient was diagnosed with hip flexor tendonitis, instructed to limit exercises for two weeks, and was prescribed an oral steroid dose pack.The patient did well until a year ago, when reported to the care team of worsening groin pain along with difficulty raising leg.The patient was given an ultrasound and fluoroscopically guided right psoas bursa injection.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, b5, g2, g3, g6, h1, h2, h3, h6, h11.The following sections were corrected: g1-2.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.Review of the complaint histories identified additional similar complaints for the reported items and no additional similar complaints for the reported part and lot combinations.Medical records were received and reviewed by a healthcare professional.Reported event was confirmed by review of medical records.Based on the available information, the reported event can be confirmed, but a definitive root cause cannot be established.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: BIOLOX OPTION TYPE 1 TPR SLEVE +3
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21444500
• Report Number: 3002806535-2025-00092
• Device Sequence Number: 12731235
• Product Code: LZO
• UDI-Device Identifier: 00880304521964
• UDI-Public: (01)00880304521964(17)280906(10)2938731
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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: 650-1067
• Device Lot Number: 2938731
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2018
• 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 Sex: Female
• Patient Weight: 83 KG
• Patient Race: White