MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71332752
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had left total hip replacement (b)(6) 2016.Patient had dislocated hip on an unknown date and again had second dislocation on (b)(6) 2020.Patient was reviewed by surgeon who determined revision surgery was required to treat unstable hip.Revision surgery completed on (b)(6) 2020, where lateralised liner was used with +4mm femoral head to increase offset and leg length.Surgeon was happy that these revised implants gave the hip greater stability.
Additional Manufacturer Narrative
Results of investigation: it was reported that the patient was revised as the surgeon determined a revision surgery was required to treat unstable hip.The associated devices, used in treatment, were not returned for evaluation.Thus the product analysis could not be performed.A review of manufacturing records did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts 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 products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.A clinical analysis noted that one x-ray dated (b)(6) 2020 (2 weeks prior to the revision) and one undated x-ray demonstrated a reduced hip.No other clinical information was provided.The impact to the patient beyond the two dislocations and revision cannot be determined.This reported failure has been identified in the instructions for use and risk management files.Some potential causes of the reported event could include but are not limited to traumatic injury, patient anatomy or limited range of motion.Without the return of the actual products involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, the complaint will be reopened.

• Brand Name: R3 0 DEG XLPE ACET LNR 36MM X 52MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 10002867
• Report Number: 1020279-2020-01388
• Device Sequence Number: 11285944
• Product Code: MBL
• UDI-Device Identifier: 03596010597984
• UDI-Public: 03596010597984
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2020

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: 71332752
• Device Catalogue Number: 71332752
• Device Lot Number: 16DM10461
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention