MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 32MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED

Catalog Number	650-1056
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Synovitis (2094); Joint Dislocation (2374); Metal Related Pathology (4530); Aseptic loosening (4883); Periprosthetic fracture (4902)
Date of Event	07/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.Cer option type 1 tpr sleve -3; item number# 650-1065; lot number# 980920.Taperloc stem; item number# 14-13200; lot number# 604300.32mm i.D.Size gg elevated rim liner use with 48mm o.D.Size gg shell; item number# 00875200832; lot number# 630203144.Screws plus rings; item number# unknown; lot number# unknown; qty: 2.10 hole plate; item number# unknown; lot number# unknown.Screws; item number# unknown; lot number# unknown; qty: 7.G2: foreign - event occurred in canada.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 a left hip revision approximately 5-months post implantation due to dislocation and noted the patient has been falling due to unknown cause.During the revision it was noted the acetabulum was loose, synovitis, screw fractures and significant damage to the bone structures of the pelvis with the entire posterior-superior roof is virtually absent and fragmented.The shell, liner, head, taper adapter, plate, screws, and zimmer frame are exchanged with competitor acetabular construct and allograft.It was confirmed that no further information could be provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4) this follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d9; g2; g3; g4; g6; h2; h3; h6; h11.The reported event was confirmed by review of medical records.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 history identified additional similar complaints for the reported item and the part and lot combination.Medical records were provided and reviewed by a health care professional.The review identified the patient has a history of multiple hip surgeries and multiple falls underwent revision for dislocation of a total hip arthroplasty with loosening of the acetabular component.The latest fall reportedly led to loosening and dislocation.In surgery, inflammatory fluid, significant synovitis, and metal corrosion debris were found.The ceramic head showed damage from contact with screws, the acetabular component was completely loose and removed, and there was major pelvic bone loss with an absent/fragmented posterosuperior acetabular roof.Broken screws and prior fixation hardware were removed, the prior acetabular fracture was noted to be consolidated without pelvic dissociation, and allograft was used to fill the defect.No intraoperative complications were reported.The reported inadvertent fall, with the specific circumstances not identified, may have contributed to the event.However, a definitive root cause could not be established based on the information available.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.

• Brand Name: CER BIOLOXD OPTION HD 32MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23904916
• Report Number: 3002806535-2025-00668
• Device Sequence Number: 15375146
• Product Code: LZO
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/17/2024
• Device Catalogue Number: 650-1056
• Device Lot Number: 007000
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2014
• 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: N
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female