MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN ORTHOPAEDIC RECONSTRUCTION DEV; PROSTHESIS, HIP, SEMI-CONSTRAIND, MET/CERAM/POLY, CEMNTD OR NON-POROUS, UNCEMENT

Model Number	71342808
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	12/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that after the revision surgery, another medical intervention under anesthesia (closed reposition) was performed due to a luxation.The patient outcome was positive.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation but the pictures were reviewed and the failure mode was confirmed.The clinical/medical investigation concluded that, the provided x-rays confirm the luxation and reduction.The medical root cause of the luxation cannot be concluded with the available information; however, the twisting motion of the patient cannot be ruled out.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.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: UNKN ORTHOPAEDIC RECONSTRUCTION DEV
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAIND, MET/CERAM/POLY, CEMNTD OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11390950
• Report Number: 1020279-2021-01641
• Device Sequence Number: 1167342
• Product Code: LZO
• UDI-Device Identifier: 03596010474179
• UDI-Public: 03596010474179
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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 Model Number: 71342808
• Device Catalogue Number: 71342808
• Device Lot Number: 20FM01048
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 02/28/2021
• Supplement Report FDA Received Date: 07/15/2021
• 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: SHELL 75001030, LOT D176895
• Outcome Attributed to Adverse Event: Required Intervention