MAUDE Adverse Event Report: ZIMMER GMBH ALLOFIT IT ALLO-C SHELL 54/JJ; HIP IMPLANT

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 03/04/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: unknown revitan stem unknown lot and item #.Unknown smith & nephew head unknown lot and item #.Unknown longevity liner unknown item # lot 62177046.G2: foreign: belgium.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

It was reported that patient had a revision surgery due to loosening cup, approximately eleven (11) years after implantation.The patient reported pain and severe problems walking.The cup and liner were replaced without complications and the stem remained implanted.It was reported that the head, a competitor¿s product was also revised.Due diligence is in progress for this complaint; to date no additional information or product has been received.

• Brand Name: ALLOFIT IT ALLO-C SHELL 54/JJ
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER 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: 18941214
• MDR Text Key: 338135608
• Report Number: 0009613350-2024-00113
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024413269
• UDI-Public: (01)00889024413269(17)220831(10)2670158
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K003758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2024

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00875505402
• Device Lot Number: 2670158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Race: White