MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 40MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number	650-1058
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); Joint Laxity (4526); Joint Impingement (4834)
Date of Event	07/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cer option type 1 tpr sleve +3; item number# 650-1067; lot number# 3183289.40mm i.D.Size i +5mm offset liner; item number# 30154009; lot number# 64914939.Arcos 19x150mm spl tpr dist; item number# 11-300819; lot number# 687970.G7 osseoti multihole 66mm i; item number# 110010271; lot number# 7099772.Arcos con sz d hi 60mm; item number# 11-301314; lot number# 107790.Unknown trochanteric claw; item number# unknown; lot number# unknown.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 patient underwent to hip revision surgery due to experienced recurrent dislocations approximately 3 months and 17 days post-implantation, which the surgeon attributed to poor cup placement and anterior trochanteric claw fixation.A competitor cup was cemented into the existing cup, and the head and liner were exchanged.The initial stem and trochanteric claw were retained.On follow up, the patient reported high satisfaction and was progressing well.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10: g7 screw 6.5mm x 30mm; item number# 010000999; lot number# 7329339 bone screw self-tapping 6.5 mm dia.20 mm length; item number# 00625006520; lot number# j7845132.Bone screw self-tapping 6.5 mm dia.20 mm length; item number# 00625006520; lot number# 65800522.Bone screw self-tapping 6.5 mm dia.20 mm length; item number# 00625006520; lot number# j7562756.Bone screw self-tapping 6.5 mm dia.20 mm length; item number# 00625006520; lot number# j7310870.Bone screw self-tapping 6.5 mm dia.30 mm length; item number# 00625006530; lot number# j7448940.Bone screw self-tapping 6.5 mm dia.15 mm length; item number# 00625006515; lot number# j7884437.Bone screw self-tapping 6.5 mm dia.40 mm length; item number# 00625006540; lot number# 64973207.This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d2a, d10, g3, g6, h2, h3, h6, h11.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 no additional similar complaints for the reported part and lot combination.Medical records and radiographs were provided from the revision surgery and reviewed by a hcp.The review indicated that the patient previously underwent a one-stage revision for infection; however, the components were placed in poor position, resulting in recurrent instability on three occasions.Excess fluid was evacuated from the joint, and circumferential debridement was performed.The acetabular cup was found to be well fixed, with limited medial bone stock.The existing cup was therefore used as an augment, with a plan to cement a cup within a cup.A metal cutting burr was used to roughen the inner surface of the existing acetabular cup, and the unused acetabular screw holes were burred to allow for cement interdigitation.A depuy cup was cemented into a g7 cup.A biomet plus six ceramic head was implanted for the monoblock dual mobility construct.Further debridement of the anterior aspect of the greater trochanter and surrounding anterior soft tissues was performed, as these were identified as the primary sources of anterior impingement.The impingement was largely attributed to prior greater trochanteric fixation performed in a slightly anterior position; however, as the fixation was stable, realignment of the trochanter was not performed.The joint was closed without intraoperative complications and was stable through range of motion testing.Post-op x-ray findings: the left trochanteric claw plate remains in place and is fixed in an anterior position.A cemented monoblock cup is present within the cementless acetabular cup, which was previously positioned inappropriately.The newly cemented cup demonstrates improved inclination and appropriate anteversion.No fractures or dislocations are identified.A definitive root cause cannot be determined.However, the surgeon notes that the acetabular component was poorly positioned with anterior tissues causing impingement as the result of the prior gt fixation being performed slightly anterior.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 40MM
• 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23013655
• Report Number: 3002806535-2025-00450
• Device Sequence Number: 10038246
• Product Code: LZO
• UDI-Device Identifier: 00887868271403
• UDI-Public: (01)00887868271403(17)341205(10)3220030
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

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 Catalogue Number: 650-1058
• Device Lot Number: 3220030
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2024
• 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; SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic