MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 48MM; PRSTHSS, HP, SM-CNSTRND, UNCMNTD, MTL/PLYMR, PRS

Model Number	71337648
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to dislocation.After the total hip replacement, the post-op x-rays showed that the liner didn't engage/ lock into the cup, it must have ¿popped¿ out.Explanted devices: liner, due to extensive damaged and the ball head as it was moving on the rim of the cup, also damaging it.
Additional Manufacturer Narrative
The associated devices, used in treatment, were returned and evaluated.Only the head and liner were returned.A visual inspection of the returned devices could not confirm the stated failure mode.The head and liner are heavily damaged from implantation / insertion / extraction.The devices were manufactured in 2019.The clinical / medical investigation concluded that only one photo of the damaged device and two pages of chart sticks were provided for review.Without the relevant clinical information, a thorough medical investigation cannot be rendered.Should any additional medical information be provided, this complaint will be re-assessed.A dimensional inspection was attempted but the devices were too damaged to obtain accurate measurements.A review of complaint history did not reveal additional complaints for the listed batches.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 was previously identified.Some potential probable causes of the reported event could include improper surgical technique or device selection.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: R3 20 DEG XLPE ACET LNR 32MM X 48MM
• Common Device Name: PRSTHSS, HP, SM-CNSTRND, UNCMNTD, MTL/PLYMR, PRS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9530077
• Report Number: 1020279-2019-04631
• Device Sequence Number: 2408346
• Product Code: MBL
• UDI-Device Identifier: 03596010598479
• UDI-Public: 03596010598479
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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: 71337648
• Device Catalogue Number: 71337648
• Device Lot Number: 19AM15710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 04/14/2020
• 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