MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX OPTION, HEAD, S, ø 36/-3.0, TAPER 12/14; BIOLOX FEMORAL HEAD PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	05/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Unknown cup unknown item and lot # unknown 58/36mm zementierter constraned liner unknown item and lot # g2: foreign: switzerland customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient had a revision surgery due to dislocation, the head with the correct size was dislocated from the socket with correctly positioned tabs and correctly applied ring, without cup or ring dislocation.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Event or Problem Description
Due diligence has been completed for this complaint; to date all available additional information has been received.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: cem const lnr 58 x 36 item# 00711505836 lot #65539843, unknown cup unknown item and lot #.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 additional event information at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3; h6 the biolox option head and the cemented constrained liner were returned for investigation.The head shows metal transfers both on the articulating surface and on the chamfer.The metal transfers on the articulating surface matches the reported event of dislocation.The taper shows metal transfer coming from the metallic adapter; the metal adapter is overall inconspicuous.The backside of the liners shows damages most likely coming from the revision surgery.Of note, no traces of cement was found on the backside of the liner.The articulating surface of the liner shows some scratches and rough areas; however, it is not possible to determine if they are due to the revision surgery or if they happened during the time in vivo.The metal ring shows some scratch but it is overall inconspicuous.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Radiographs were received and reviewed from a radiologist.The imaging review included two ap lower pelvis views, two oblique lateral right hip views, and three ct images of the right hip, all undated.The assessment of the radiographs shows a dislocation of the right hip arthroplasty, though there is no evidence of fractures or implant loosening.The constraining implant remains anatomically positioned.On the ct images, there is radiopaque material, likely cement, visible within the acetabular cup or fossa.This material appears to reduce the depth of the fossa, potentially hindering the proper seating of the femoral head and contributing to the dislocation.A full evaluation of the entire ct series is recommended for a more thorough assessment of the acetabular fossa and the seating issue.Fit of the implant appears to be maintained, but the alignment is affected by the confirmed dislocation.The bone quality is noted as osteopenic, suggesting reduced bone density.The dislocation is clearly visible on both the radiographs and ct images, confirming the issue.Based on the available information, the reported event can be confirmed however 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.

• Brand Name: BIOLOX OPTION, HEAD, S, ø 36/-3.0, TAPER 12/14
• Common Device Name: BIOLOX FEMORAL HEAD PROSTHESIS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 19459310
• Report Number: 0009613350-2024-00209
• Device Sequence Number: 18122107
• Product Code: LZO
• UDI-Device Identifier: 00889024430518
• UDI-Public: (01)00889024430518(17)331211(10)3185256
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2024

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 Model Number: N/A
• Device Catalogue Number: 00877703601
• Device Lot Number: 3185256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/08/2024
• Supplement Date Received by Manufacturer: 06/12/2024; 10/24/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 06/19/2024; 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown