MAUDE Adverse Event Report: ZIMMER GMBH CLS CUP; HIP PROSTHESIS

Model Number N/A

Device Problems Biocompatibility (2886); Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problem Metal Related Pathology (4530)

Event Date 07/22/2021

Event Type  Injury  

Manufacturer Narrative

Medical product: cocr head hip impl win gen; item# : unknown; lot# : unknown.Liner hip impl win gen; item# : unknown; lot# : unknown.Therapy date: unknown.The manufacturer did not receive x-rays for review.Other source documents were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive yet the device, however it is indicated by complainant that it will be returned for investigation.As no lot number was provided, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on an unknown side and underwent revision due to metallosis.

Event Description

It was reported that the patient was implanted with cls cup on an unknown side and underwent a revision surgery due to metallosis and instability of the joint.Patient has experienced recurrent dislocations also.

Manufacturer Narrative

D10: medical product: cocr head hip impl win gen; catalog#: unknown; lot#: unknown.Liner hip impl win gen; catalog#: unknown; lot#: unknown.Therapy date: (b)(6), 2021.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additional information was received on sep 22, 2021.Additional: a1, b3, b5, d6, d10, h6.Correction: b4, g3, g6, h2, h10.The manufacturer received x-rays and other source documents for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

This product (cls spotorno, expansion shell, uncemented, 58) has been moved to associated devices, as it turned out that this shell was not revised.

Manufacturer Narrative

This product (cls spotorno, expansion shell, uncemented, 58) has been moved to associated devices, as it turned out that this shell was not revised.Note: this incident is captured in the following reports: 0009613350-2021-00472-1, 0009613350-2021-00473-1.Therefore, please delete this report from your system.

• Brand Name: CLS CUP
• Type of Device: HIP PROSTHESIS
• 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: 12432766
• MDR Text Key: 270086193
• Report Number: 0009613350-2021-00468
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male