MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 CONST 60MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	71339160
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during revision the constrained liner won't engage shell.Less than two hours of delay was reported and a backup device was available.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.The lab analysis concluded, scratches and plastic deformation were seen on the face of the poly locking ring, the inner liner, and the outer liner.Scratches were seen on the face of the femoral head.Scratches were also seen on two areas of the outer diameter of the femoral head as shown in.Scratches on the femoral head likely occurred during removal.Scratches were seen near the apex of the outer diameter of the liner.Plastic deformation was observed on the locking tabs of the liner and in two areas on the outer diameter.Liner damage was likely caused during implantation or removal of the liner.No manufacturing or material deviations were identified during this investigation.The cause of the liners inability to engage with the shell could not be determined.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.If new information is received in the future, this complaint can be re-opened.
Event or Problem Description
It was reported that during revision the constrained liner won't engage shell.More than two hours of delay was reported and a backup device was available.Device was received already.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.The lab analysis concluded, scratches and plastic deformation were seen on the face of the poly locking ring, the inner liner, and the outer liner.Scratches were seen on the face of the femoral head.Scratches were also seen on two areas of the outer diameter of the femoral head as shown in.Scratches on the femoral head likely occurred during removal.Scratches were seen near the apex of the outer diameter of the liner.Plastic deformation was observed on the locking tabs of the liner and in two areas on the outer diameter.Liner damage was likely caused during implantation or removal of the liner.No manufacturing or material deviations were identified during this investigation.The cause of the liners inability to engage with the shell could not be determined.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.If new information is received in the future, this complaint can be re-opened.

• Brand Name: R3 CONST 60MM
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8283238
• Report Number: 1020279-2019-00317
• Device Sequence Number: 19194646
• Product Code: KWZ
• UDI-Device Identifier: 00885556021330
• UDI-Public: 00885556021330
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/03/2026
• Device Catalogue Number: 71339160
• Device Lot Number: 16CM05433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 01/03/2019; 01/03/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 05/18/2019; 05/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1