MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ALLOFIT-S IT ALLOCLASSIC, SHELL FOR ACETABULUM, UNCEMENTED, 52/II; PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)

Catalog Number 00-8755-052-02

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032)

Event Date 01/12/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - associated medical devices: avenir muller stem 5 standard; item# 01.06010.005; lot# 4024111, biolox delta, ceramic femoral head, l, 36/+3.5, taper 12/14; item# 00-8775-036-03; lot# 2751305, biolox delta ceramic taper liner, size ii / 36 i.D.For use with 52 mm o.D.Size ii shell; item# 00-8775-010-36; lot# 2766836.G2 - foreign: france.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left tha was performed with no complications noted.A ct scan taken indicates the left acetabulum loosened.The patient has been experiencing pain and stiffness.A revision is tentatively scheduled in coming months.A definitive root cause cannot be determined.This complaint was confirmed based on the provided medical records.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 Description

It was reported that approximately eleven years post the initial hip implantation, the patient reported pain and stiffness.Imaging done indicates loosening of the acetabular shell.A revision is scheduled to be carried out in coming months.Attempts have been made and no further information has been provided.

• Brand Name: ALLOFIT-S IT ALLOCLASSIC, SHELL FOR ACETABULUM, UNCEMENTED, 52/II
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 17297818
• MDR Text Key: 318970926
• Report Number: 0009613350-2023-00381
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00889024413252
• UDI-Public: (01)00889024413252(17)240630(10)2762763
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/11/2023

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 00-8755-052-02
• Device Lot Number: 2762763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female