MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 CONST 64MM; PROSTHESIS, KNE, FMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMR

Model Number	71339164
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during revision surgery, the surgeon noticed that there was a considerable amount of impingement, and he could not use the liner that he was planning to the implant (64mm tripolar liner).Therefore, he decided to change to a more traditional liner (offset liner).
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation, the reported event could not be confirmed.The clnical/medical team concluded, the significant complexity due to ¿previous surgery and deformity¿ could have contributed to the intra-op anterior impingement of the r3 liner and subsequent unsuccessful implantation(b)(4); however this could not be definitively concluded.The patient impact beyond a possible minor surgical delay during which the constrained liner was trialed and exchanged for a lateralized liner could not be determined as no delay was reported.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment could be rendered at this time.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 have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.

• Brand Name: R3 CONST 64MM
• Common Device Name: PROSTHESIS, KNE, FMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038246
• MDR Report Key: 10025989
• Report Number: 1020279-2020-01464
• Device Sequence Number: 16878322
• Product Code: HRY
• UDI-Device Identifier: 00885556020852
• UDI-Public: 00885556020852
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: 71339164
• Device Catalogue Number: 71339164
• Device Lot Number: 15FM02557
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 04/05/2020
• Supplement Date Received by Manufacturer: 07/16/2020; 10/23/2023
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 07/21/2020; 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71302804 / LOT # 12FM19040; 71302808 / LOT # 13JM09702
• Patient Sex: Unknown