MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG; PROSTHSIS,HIP,SMI-CONSTRIND,MTAL/POLYMR,POROUSUNCMNTD

Model Number POLARCUP XLPE INSERT 43/22 NON-CEM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2020

Event Type  Injury  

Event Description

It was reported that during procedure it was noticed that the polarcup insert measures 32, should be 37 and because of that it popped out.An s+n backup device was available.There is no information about surgical delays.

Manufacturer Narrative

Additional information received by the customer has identified that this event has been already reported under 9613369-2020-00070.The new information confirms that this is a duplicate complaint, therefore, if further details are provided in future confirming the opposite, our files will be updated accordingly and a further report will be submitted outlining both events details and our investigations performed.

• Type of Device: PROSTHSIS,HIP,SMI-CONSTRIND,MTAL/POLYMR,POROUSUNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10117202
• MDR Text Key: 193936700
• Report Number: 9613369-2020-00095
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K110135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: POLARCUP XLPE INSERT 43/22 NON-CEM
• Device Lot Number: B1913078
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/06/2020
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 06/03/2020
• Supplement Dates Manufacturer Received: 05/06/2020
• Supplement Dates FDA Received: 06/30/2020
• Patient Sequence Number: 1