MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71335754
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a total hip replacement was performed on 2016 using r3/cpcs to treat neck of femur fracture in of a female patient born in (b)(6).It was reported that the patient had dislocated several times over the past 4 years.During the revision operation, surgeon noted that the femoral head was scratched, and appeared to be dislocating posterior, and that the femoral stem was slightly re-troverted.Surgeon noted that this was most likely the reason for the dislocation.During revision surgery, the femoral head, femoral stem, and cup liner were removed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to multiple dislocations.During the revision operation, surgeon noted that the femoral head was scratched, and appeared to be dislocating posteriorly, and that the femoral stem was slightly retroverted.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part 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 product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found the event as a potential adverse event.A medical analysis noted that it was stated in the original complaint that the surgery was ¿performed by a training registrar¿.It is not clear if this surgeon feels that this could have been a procedural variance.Some potential causes of the reported event could include but are not limited to surgical technique used or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, this complaint will be reopened and reevaluated.We consider this investigation closed.

• Brand Name: R3 20 DEG XLPE ACET LNR 36MM X 54MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10209572
• Report Number: 1020279-2020-02829
• Device Sequence Number: 19359892
• Product Code: JDI
• UDI-Device Identifier: 03596010598349
• UDI-Public: 03596010598349
• 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): 09/09/2020

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 Expiration Date: 08/08/2025
• Device Model Number: 71335754
• Device Catalogue Number: 71335754
• Device Lot Number: 15HM06351
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 09/09/2020
• 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