MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG +4 XLPE ACET LNR 28MM X 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71337746
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that primary procedure was performed on (b)(6) 2015.Patient dislocated 2 months ago and the hip was relocated but three weeks ago patient dislocated again bending over pulling weeds.Revision surgery was performed and oxinium fem hd 12/14 28mm -3 and r3 20 deg +4 xlpe acet lnr 28mm x 46mm were explanted.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that based on the limited information provided, the root cause of the reported dislocations were most likely the lack of posterior hip precautions (status post recent hip dislocation with subsequent reduction) finally exacerbated when the patient was reportedly ¿bending over pulling weeds¿.No details were provided on the first dislocation; however, it would not be uncommon for the surrounding tissues to be disrupted and/or weakened following the first reported dislocation/reduction leading to a higher risk.The patient impact beyond the reported recurrent dislocation and subsequent revision procedure could not be determined.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.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 have no 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 and potential harm was previously identified.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.Without the return of the actual product involved or product information, our investigation could not proceed.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.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on the limited information provided, the root cause of the reported dislocations were most likely the lack of posterior hip precautions (status post recent hip dislocation with subsequent reduction) finally exacerbated when the patient was reportedly ¿bending over pulling weeds¿.No details were provided on the first dislocation; however, it would not be uncommon for the surrounding tissues to be disrupted and/or weakened following the first reported dislocation/reduction leading to a higher risk.The patient impact beyond the reported recurrent dislocation and subsequent revision procedure could not be determined.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.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.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, lifetime of device, and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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: R3 20 DEG +4 XLPE ACET LNR 28MM X 46MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10646487
• Report Number: 1020279-2020-05228
• Device Sequence Number: 11388790
• Product Code: MBL
• UDI-Device Identifier: 03596010598554
• UDI-Public: 03596010598554
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2021

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: 71337746
• Device Catalogue Number: 71337746
• Device Lot Number: 18DM20771
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 06/26/2021; 10/04/2021
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 06/28/2021; 10/05/2021
• 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