MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET HIP SYSTEM 28MM DIA COCR MOD HD -6MM NK; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374); Muscle/Tendon Damage (4532)
Date of Event	10/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a hip procedure.Subsequently, the patient was revised approximately 4 months later due to recurrent dislocations.Due to the degradation of the bone and soft tissue in the hip, the surgeon determined that the hip was no longer stable and would keep dislocating.Therefore, all components were removed, and the hip was fused.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).D10: unk biomet ha modular proximal body size b x60mm unk biomet arcos 13x150mm splined stem unk smith & nephew reflection all poly cup unk smith & nephew screws unk smith & nephew contour acetabular recon cage cat# 00711505028 lot# 64835874 28mm i.D.With constraining ring cemented constrained liner use with 50mm o.D.Shell / do not use with skirted heads.G2: foreign: australia the 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4.G3.G6.H2.H6 suggested component code: mechanical (g04) - head.H11.Visual examination of the provided pictures identified the explanted head covered in bio-debris.No further evaluation could be made from the provided photos.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: head dislocated from constrained liner, cemented constrained liner failure.Patient bone and soft tissue is degraded meaning hip was no longer stable.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: dislocation of the femoral head and acetabular cup liner.Possible metallosis of the left hip.Loose screws seen.A definitive root cause cannot be determined.As per ifu , only authorized combinations on zimmer and biomet products should be used.Using competitor products is considered off-label use.It is unknown if off-label use caused or contributed to the reported event.The complaint is confirmed based on the medical record findings.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
There is no update to the prior event description provided.

• Brand Name: BIOMET HIP SYSTEM 28MM DIA COCR MOD HD -6MM NK
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20517420
• Report Number: 0001825034-2024-02498
• Device Sequence Number: 18083852
• Product Code: JDG
• UDI-Device Identifier: 00887868308253
• UDI-Public: (01)00887868308253(17)290823(10)581300
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K942479
• 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
• Report Date (Section B): 12/11/2024

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 163660
• Device Lot Number: 581300
• 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: 10/10/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2019
• 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
• Patient Weight: 51 KG