MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 32MM X 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71339548
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed.It is unknown the reason for this revision.Liner was removed.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed.The reason for this revision is unknown.The affected oxinium femoral head and r3 articular insert were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the insert did not reveal any deviation from the standard manufacturing processes.The lot number for the femoral head was not provided.Thus, a review of the manufacturing records for this part cannot be performed.A review of the complaint history for the listed insert 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 or adverse event could not be corroborated.A clinical analysis noted that the x-ray provided is undated and shows a greater trochanteric non-union fracture with a fracture plate and cerclage wires.There is a broken screw near the distal tip of the stem.The prosthetic head doesn¿t appear centered in the shell but this is a single view.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported revision cannot be confirmed.The impact to the patient beyond the revision cannot be concluded.No further clinical assessment is warranted at this time.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: R3 0 DEG XLPE ACET LNR 32MM X 48MM
• 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: 8862831
• Report Number: 1020279-2019-02895
• Device Sequence Number: 14141837
• Product Code: MBL
• UDI-Device Identifier: 03596010598790
• UDI-Public: 03596010598790
• 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 Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2019

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 Catalogue Number: 71339548
• Device Lot Number: 17MM13590
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 11/04/2019
• 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