MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Scar Tissue (2060); Joint Dislocation (2374); Muscle/Tendon Damage (4532)
Date of Event	01/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had an initial right total hip arthroplasty performed approximately one year ago.Subsequently, the patient was revised due to recurrent dislocations.During the revision, it was noted that the patient¿s initial capsular repair was completely torn on the posterior capsule which had scarred down posteriorly causing dislocations.The scar tissue was removed which increased stable range of motion.The head, neck, and liner were replaced with a constrained system which further enhanced stable range of motion.The initial cup and stem were left intact, and the procedure was completed without complications.Diligence is complete and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D10.Liner standard 3.5 mm offset 36 mm i.D.For use with 58 mm o.D.Shell item# 00630505836 lot#64970915.Modular neck c 12/14 neck taper use with +0 heads only item#00784803300 lot#65603456.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.
Additional Manufacturer Narrative
No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.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.Complaints are monitored per complaint trending process in order to identify potential adverse trends.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed.Followed by a revision was performed due to recurrent dislocations.During the revision it was noted there was a tear of the capsular repair and a large amount of scar tissue.The head, liner, and neck were revised with no complications noted.Op note report presence of a capsular tear.With the available information, it cannot be established if this issue is a consequence of the multiple dislocations or, instead, a contributing factor leading to the reported event.A definitive root cause cannot be determined.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 additional event information.

• Brand Name: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP
• 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: 18828318
• Report Number: 0009613350-2024-00082
• Device Sequence Number: 12709414
• Product Code: LZO
• UDI-Device Identifier: 00889024430365
• UDI-Public: (01)00889024430365(17)330201(10)3132882
• 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: 2023
• 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): 05/09/2024

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: 00877503602
• Device Lot Number: 3132882
• 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: 02/08/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 93 KG