MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONTINUUM TRABECULAR METAL 58MM O.D. SIZE LL POROUS UNCEMENTED; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Malposition of Device (2616); Noise, Audible (3273)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial hip procedure.Subsequently, the patient was revised approximately 7 years later due to poor alignment of the acetabular component.There was reproducible audible squeaking and crepitus by the patient.It was reported that no further information was available.
Additional Manufacturer Narrative
(b)(4).D10: cat# 00625006530 lot# 63535924 bone scr 6.5x30 self-tap.Cat# 00625006540 lot# 63214016 bone scr 6.5x40 self-tap.Cat# 00877501336 lot# 2738375 bioloxâ® delta ceramic taper liner, size ll / 36 i.D.For use with 58 mm o.D.Size ll shell.Cat# 11-300816 lot# 124690 arcos 16x150mm spl tpr dist.Cat# 11-301304 lot# 213170 arcos con sz d std 60mm.Cat# 650-0661 lot# 2017050061 delta ceramic fem hd 36/0mm.G2: foreign: australia.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was not returned by the hospital.The investigation is in process.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.Visual examination of the provided pictures identified the explanted liner and head.Pictures were not provided of the explanted shell.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: anatomic alignment of the right hip arthroplasty.The provided x-ray was undated.A definitive root cause cannot be determined.The positioning of the implants is surgeon discretion, and it is unknown if the implant may have moved or was placed in a way that was not aligned.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: CONTINUUM TRABECULAR METAL 58MM O.D. SIZE LL POROUS UNCEMENTED
• 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: 19475386
• Report Number: 0001822565-2024-01908
• Device Sequence Number: 6875715
• Product Code: JDI
• UDI-Device Identifier: 00889024151468
• UDI-Public: (01)00889024151468(17)270430(10)63640013
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 09/26/2024

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 Model Number: N/A
• Device Catalogue Number: 00875705801
• Device Lot Number: 63640013
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2017
• 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: Required Intervention; Hospitalization
• Patient Sex: Male