MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	04/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a primary total arthroplasty of the left hip.The patient was presented with pain, instability, and difficulty walking.The prosthesis was loose and revised.
Additional Manufacturer Narrative
(b)(4).D1:femoral stem - revision taper - nitrided cementless 18 mm diameter 185 mm stem length.D10: unknown zmr body unknown.G2: foreign: brazil.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 and/or corrected information.Updated: g3, g6, h2, h3, h6.Proposed component code: mechanical (g04)- stem.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event for the stem.Review of complaint history found no additional related issues for this item and the reported part and lot combination for the stem.Medical records were not provided.A definitive root cause cannot be determined.This complaint cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: FEMORAL STEM
• Common Device Name: PROSTHESIS, HIPS
• 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: 19166560
• Report Number: 0001822565-2024-01373
• Device Sequence Number: 7349354
• Product Code: LPH
• UDI-Device Identifier: 00889024160859
• UDI-Public: (01)00889024160859(17)270831(10)63759824
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K992667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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: 00998201818
• Device Lot Number: 63759824
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2017
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown
• Patient Weight: 104 KG