MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRABECULAR METAL 28MM I.D. WITH CONSTRAINING RING CEMENTED CONSTRAINED LINER; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) d10: unknown competitor head unknown cup and locking ring g2: foreign: new zealand the customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient underwent an initial hip procedure on an unknown date.Subsequently, the patient underwent a revision due to recurrent dislocations.The constrained liner and ring were removed.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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 related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: superior and posterior dislocation of an undersized right femoral head total hip arthroplasty.Possible dislocation of the locking ring.Deficient medial wall of the acetabulum.Acetabuli protrusion is present as a result.A definitive root cause cannot be determined for the initial dislocation.Per instructions of this liner, it states that closed reduction of this device is not possible.Treatment of device dislocation will require additional surgery.Also, the liner was used with a competitor head, however it is unknown if this combination caused or contributed to the reported event.A technical report will be sent to the initial surgeon for the use of competitor products with our devices.A technical report will not be sent for the closed reduction of the constrained liner, as it is unknown who performed the closed reduction.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 information at the time of this report.

• Brand Name: TRABECULAR METAL 28MM I.D. WITH CONSTRAINING RING CEMENTED CONSTRAINED LINER
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19221218
• Report Number: 0001822565-2024-01443
• Device Sequence Number: 15245263
• Product Code: KWZ
• UDI-Device Identifier: 00889024130241
• UDI-Public: (01)00889024130241(17)210430(10)63312434
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K072121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/26/2024

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 Expiration Date: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00711505028
• Device Lot Number: 63312434
• 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: 04/09/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2016
• 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: Unknown