MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CLS SPOTORNO, EXPANSION SHELL, UNCEMENTED, 50; METALLIC ACETABULUM PROSTHESIS

Model Number N/A

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 07/15/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: metasul cls spotorno, insert, 50/28 item# 60132850 lot# a893595.Foreign source: italy.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that patient underwent an initial hip arthroplasty.Subsequently, a revision procedure due to implant fracture was performed.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.No product was returned.Visual examination of the provided pictures identified cup fracture, however the photographs did not clearly show the fracture surface.Device is used for treatment.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.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.

• Brand Name: CLS SPOTORNO, EXPANSION SHELL, UNCEMENTED, 50
• Type of Device: METALLIC ACETABULUM PROSTHESIS
• 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: 15614738
• MDR Text Key: 301828201
• Report Number: 0009613350-2022-00542
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/15/2004
• Device Model Number: N/A
• Device Catalogue Number: 945019
• Device Lot Number: B403668
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/1999
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 72 KG