MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 CONST 58MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Model Number	71339158
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during revision the liner would not engage into cup.A delay of over 2 hours was reported.No injury reported.A back up device was available.
Additional Manufacturer Narrative
Results of investigation: it was reported that during revision the liner would not engage into cup.A delay of over 2 hours was reported.No injury reported.A back up device was available.The affected r3 constrainted liner, used in treatment, was returned and evaluated.A visual inspection of the returned device showed signs of burnishing and scratching on the rim region of the acetabular liner, probably from attempted insertion.Dimensional analysis could not be performed as the damage/deformation around the edges would not allow for accurate measurement.Our investigation including a review of manufacturing records did not reveal any deviation from the standard manufacturing processes.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Some potential causes of the reported event could include but are not limited to size of device or user/procedural variance.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: R3 CONST 58MM
• 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: 8260642
• Report Number: 1020279-2019-00201
• Device Sequence Number: 2081005
• Product Code: KWZ
• UDI-Device Identifier: 00885556020876
• UDI-Public: 00885556020876
• 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
• Report Date (Section B): 11/17/2020

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: 08/02/2026
• Device Model Number: 71339158
• Device Catalogue Number: 71339158
• Device Lot Number: 16DM13899A
• 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: 11/17/2020
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1