MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX, DELTA, CERAMIC FEMORAL HEAD, M, ø 32/0, TAPER 12/14; BIOLOX HIP PROTHESIS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Scar Tissue (2060); Joint Dislocation (2374)
Date of Event	09/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 00630505032 lot# 62316022 liner standard 32 mm i.D.For use with 50/52/54 mm o.D.Shells.Cat# 00784802300 lot# 62201684 modular neck g 12/14 neck taper use with +0 heads only.Cat# 00771301200 lot# 62163671 mod ml taper fem st 12.5.Cat# 00620205422 lot# 62324616 shell porous with cluster holes 54 mm.Cat# 00625006535 lot# 62249780 bone screw self-tapping 6.5 mm dia.35 mm length.Cat# 00625006535 lot# 62149027 bone screw self-tapping 6.5 mm dia.35 mm length.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient had a left total hip arthroplasty.The patient did well until sustaining an injury while at work.It was reported that he was standing on boxes or some platform that spread apart, and he did the splits and dislocated his left hip which prior has not had any dislocations.Since that time, he has had 12 more dislocations.The patient was revised approximately 11 years post-implantation, during which abundant scar tissue was removed.The shell and stem were well-seated and remained intact.The head, liner, and neck were replaced without complication.Due diligence has been completed for this complaint; to date all available additional information has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.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.The patient underwent an initial left tha, due to osteoarthritis.The patient had been doing well until sustaining a workplace injury.Reportedly, he was standing on boxes or a platform that gave way, causing him to do the splits and dislocate his left hip an injury he had never experienced before.Since that initial dislocation, he has suffered 12 subsequent dislocations.After 11 years post-implantation, the patient underwent revision surgery.During the procedure, a significant amount of scar tissue was removed.The acetabular shell and femoral stem were confirmed to be well-seated and intact.The head, liner, and neck components were replaced without complications.Based on the available information, the reported event can be confirmed.It can be assumed that the issue was most likely caused by the fall the patient sustained.However, with the available information, a definitive root cause cannot be stablished.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: BIOLOX, DELTA, CERAMIC FEMORAL HEAD, M, ø 32/0, TAPER 12/14
• Common Device Name: BIOLOX HIP PROTHESIS
• 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: 20517387
• Report Number: 0009613350-2024-00494
• Device Sequence Number: 7718261
• Product Code: LZO
• UDI-Device Identifier: 00889024276741
• UDI-Public: (01)00889024276741(17)221130(10)2676393
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K200112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

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 Expiration Date: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 00877503202
• Device Lot Number: 2676393
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2012
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 84 KG