MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER 10 DEGREE ELEVATED RIM 3.5 MM OFFSET 36 MM I.D.; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: australia.D10: cat# 65620005821, lot# 63382517, shell porous without holes 58 mm o.D.Cat# 00811400410, lot# 63724908, femoral stem 12/14 neck taper.Cat# 4000-8775-036-04, lot# 2890293, delta ceranic fem head + 7 36mm.Cat# 00801102028, lot# 63862008, allen medullary cement plugs.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.
Event or Problem Description
It was reported that approximately 4 years post implantation of a right total hip arthroplasty, the patient was revised due to dislocation.No additional information available.
Additional Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number: (b)(4) ponce.
Event or Problem Description
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 2648920 ponce.

• Brand Name: LINER 10 DEGREE ELEVATED RIM 3.5 MM OFFSET 36 MM I.D.
• Common Device Name: PROTHESIS, 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: 18687811
• Report Number: 0001822565-2024-00491
• Device Sequence Number: 6509880
• Product Code: LPH
• UDI-Device Identifier: 00889024124813
• UDI-Public: (01)00889024124813(17)210731(10)63417809
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K002960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 04/10/2024

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: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00631005836
• Device Lot Number: 63417809
• 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: 02/07/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2016
• 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
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male