MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71337654
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that a normal total hip arthroplasty surgery was performed.The liner did not engage in the r3 shell, even after several attempts.A new liner was opened (same part number and same lot number).The new liner locked in place immediately, as intended.A procedural delay of between 0-30 min occurred.No patient injury.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection was completed but could not confirm the state failure.There are gouges and minor damage to the liner.The liner exhibits deep scratches/deformation on the id and id rim.A dimensional analysis could not be completed due to damage to the liner from attempting to insert it into the shell.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Additional information: d8/d9.

• Brand Name: R3 20 DEG XLPE ACET LNR 32MM X 54MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11069500
• Report Number: 1020279-2020-07751
• Device Sequence Number: 3206534
• Product Code: JDI
• UDI-Device Identifier: 03596010598509
• UDI-Public: 03596010598509
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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 Model Number: 71337654
• Device Catalogue Number: 71337654
• Device Lot Number: 20BM04549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1