MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CON LNR 0DEG 26ID 50-52OD SZ E; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Model Number	71323114
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the first revision tka surgery was on (b)(6) 2018.Patient suffered dislocation of femoral head and retainer ring from acetabular shell and constrained liner construct.Primary surgery date unknown.Second revision (b)(6) 2020.No injury reported except need for revision.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that the root cause of the first episode of dislocations cannot be concluded.The length of time insitu with normal ware may have contributed to the issue.The stated poor gluteal musculature and the reported ¿traumatic event of a forward flexion and the popping of the device¿ may have contributed to the cause of the second episode dislocations.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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 product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or 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.We consider this investigation closed.

• Brand Name: CON LNR 0DEG 26ID 50-52OD SZ E
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10653086
• Report Number: 1020279-2020-05283
• Device Sequence Number: 16826276
• Product Code: KWZ
• UDI-Device Identifier: 03596010510884
• UDI-Public: 03596010510884
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K033442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/24/2023
• Device Model Number: 71323114
• Device Catalogue Number: 71323114
• Device Lot Number: 13CM15936
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 06/26/2021
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LNR ADPTR 71323144/LOT 15HM00866
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 86 YR