MAUDE Adverse Event Report: Biomet UK Ltd. CER BIOLOXD OPTION HD 36MM; Prosthesis, hip, semi-constrained, metal/ceramic/polymer

Catalog Number	650-1057
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient reported ongoing extreme pain and swelling after the revision.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cer option type 1 tpr sleve +6; item number# 650-1068; lot number # 3213292 palacos cement x2; item number# 5036966; lot number # 96771058, g7 osseoti 4 hole shell 54mm f; item number# 110010245; lot number # 65915577, echo hip fx lat femoral 9mm; item number# 12-151409; lot number # 65993051, versys stem centralizer; item number# 7859-10; lot number # 65918413, 36mm i.D.Size f neutral liner; item number# 30103606; lot number # 67675158.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.

• Brand Name: CER BIOLOXD OPTION HD 36MM
• Common Device Name: Prosthesis, hip, semi-constrained, metal/ceramic/polymer
• Manufacturer (Section D): Biomet UK Ltd.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• 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 ; +1(574)526-0384
• MDR Report Key: 50190642
• Report Number: 3002806535-2026-00303
• Device Sequence Number: 20363931
• Product Code: LZO
• UDI-Device Identifier: 00887868271397
• UDI-Public: (01)00887868271397(17)350513(10)3236263
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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 Catalogue Number: 650-1057
• Device Lot Number: 3236263
• 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: 07/22/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: See H11 narrative.
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Female
• Patient Weight: 170 LB