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

Catalog Number	650-1056
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) d10 cer option type 1 tpr sleve -3; item number# 650-1065; lot # 980920, taperloc stem; item number# 14-13200; lot # 604300, 32mm i.D.Size gg elevated rim liner use with 48mm o.D.Size gg shell; item number# 00875200832; lot # 630203144.Screws plus rings; item number# unknown; lot # unknown; qty# 2.10 hole plate; item number# unknown; lot # unknown.Screws; item number# unknown; lot # unknown; qty# 7.Zimmer frame; item number# unknown; lot # unknown.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 1-year post implantation due to traumatic dislocation.During the procedure, the hip was easily reduced without further fractures noted on x-rays.A zimmer frame was implanted to prevent flexion and internal rotation without complications.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; d2a; g2; g3; 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 that the patient has a history of revisions, with the most recent surgery occurring.The patient experienced a traumatic dislocation that resulted in the placement of a frame to prevent flexion and internal rotation.No other complications were noted.The patient experienced a traumatic dislocation therefore it is possible that the trauma cause or contributed to the dislocation.However, based on the available information a definitive root cause could not 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.

• Brand Name: CER BIOLOXD OPTION HD 32MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• 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: 23906675
• Report Number: 3002806535-2025-00679
• Device Sequence Number: 13021447
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,Company Representative
• 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: Initial
• 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