MAUDE Adverse Event Report: ZIMMER GMBH CLS SPORTORNO CEMENTLESS CUP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical devices: metasul cls sportorno liner catalog no# unknown; lot no# unknown, therapy date : unknown.The manufacturer did not receive x-rays.The manufacturer received njr letter for review.The manufacturer did not receive the device 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.(b)(4).

Event Description

Cls sportorno cementless cup and metasul cls sportorno liner appear to have a ptir (patient time incidence rate) twice that of their group.As per the report there were total 210 primary surgery performed with cls sportorno cementless cup and metasul cls sportorno liner.A total of 28 revision cases have been registered.

Manufacturer Narrative

Investigation results were made available.A complaint history review, including part and lot specific investigation, could not be performed as the item number is unknown.We were informed by the uk national joint registry (njr) that the product brand cls spotorno cup appears to have a ptir (patient time incidence rate) above the average for its group's ptir.Based on the report there were 210 primary surgeries performed and a total of 28 revision cases have been registered.No individual case information such as part / lot number, event description, harm and hazardous situation has been reported, therefore no case specific investigations could be performed.Further, complaints are monitored through monthly complaint review in order to identify potential adverse trends.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

Event Description

No event update.

• Brand Name: CLS SPORTORNO CEMENTLESS CUP
• Type of Device: CLS SPORTORNO CEMENTLESS CUP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9389773
• MDR Text Key: 168446685
• Report Number: 0009613350-2019-00718
• Device Sequence Number: 1
• Product Code: KWY
• 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,other,study
• Type of Report: Initial,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2019
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention