MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH LINER, S

Model Number N/A

Device Problem Noise, Audible (3273)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: dpsc screw, 21mm; catalog#: 01.04440.021; lot#: 2995206.Dpsc screw, 36mm; catalog#: 01.04440.036; lot#: 2994818.Therapy date: unknown.The manufacturer received other source documents for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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.(b)(4).

Event Description

Patient was implanted on an unknown side and started experiencing pain and clicking noise in the shoulder.The shoulder can be moved normally but the patient refers a weird noise.

Manufacturer Narrative

It was discovered that this device or similar device is not registered in the us.Manufacturer report number 0009613350-2020-00499.Please invalidate this case from your system.Zimmer¿s reference number of this file is (b)(4).

• Brand Name: LINER, S
• Type of Device: LINER
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10745611
• MDR Text Key: 213405605
• Report Number: 0009613350-2020-00499
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 01.04440.012
• Device Lot Number: 2991234
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization