MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71335756
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374); Subluxation (4525)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the r3/polar construct was implanted on tuesday (b)(6) 2020 was brought back to theatre for a revision due to dislocation.It was found that the xlpe liner was not locked into the cup.The patient underwent a manipulation under anaesthetic on thursday (b)(6) to relocate the hip, then revision surgery on friday (b)(6) as the hip was still dislocating.A new liner and head were implanted.The new liner seemed to engage in the cup well.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is heavily damaged around the lock detail suggesting that it was not locked into the shell.The clinical medical investigation concluded that this complaint from new zealand reports a revision was performed on an r3 hip secondary to dislocation.It was communicated that no further documentation would be forthcoming.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A dimensional inspection was attempted but the device was too damaged from implantation, disassociation and extraction to obtain accurate measurements.A review of complaint history did not reveal additional complaints for the listed batch.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 do not have 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 was previously identified.Possible causes could include but not limited to traumatic injury, surgical technique or size of device.Based on this investigation, the need for corrective action is not indicated.Should 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: R3 20 DEG XLPE ACET LNR 36MM X 56MM
• 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: 10281500
• Report Number: 1020279-2020-03254
• Device Sequence Number: 485401
• Product Code: JDI
• UDI-Device Identifier: 03596010598356
• UDI-Public: 03596010598356
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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: 71335756
• Device Catalogue Number: 71335756
• Device Lot Number: 19JM05511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Received by Manufacturer: 06/21/2020
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 06/24/2021
• 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