MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71332752
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, after a thr procedure, the patient was revised because a 52 liner was implanted into a 54 shell.The patient outcome is unknown.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per the complaint details, this case represents a procedure variance and does not represent a device malfunction.Based on the limited information provided, the patient was revised because a 52 liner was implanted into a 54 shell by mistake.The impact to the patient beyond that which has been reported cannot be determined.Should any additional medical information be provided, this complaint would be re-assessed.A review of complaint history did not revealed additional complaints for the listed device for the same failure mode.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.Possible causes could include but not limited to user error.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 0 DEG XLPE ACET LNR 36MM X 52MM
• 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: 11109063
• Report Number: 1020279-2021-00035
• Device Sequence Number: 17043095
• Product Code: JDI
• UDI-Device Identifier: 03596010597984
• UDI-Public: 03596010597984
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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: 71332752
• Device Catalogue Number: 71332752
• Initial Date Received by Manufacturer: 12/13/2020
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71331954 R3 3 HOLE HA CTD ACET SHELL 54MM; 71331954 R3 3 HOLE HA CTD ACET SHELL 54MM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention