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	Break (1069)
Health Effect - Clinical Codes	Discomfort (2330); Injury (2348)
Date of Event	08/31/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to the surgeon due to increase discomfort to her hip where she had a total hip replacement a year ago.An x-ray of her hip shows that the outer metal ring from the r3 constrained liner has broken off.Xray attached.As this outer ring does not affect the locking mechanism of the liner to the cup and the hip is still quite stable, the surgeon decided to leave it as revision surgery may pose bigger risks.The surgeon will continue to monitor closely changing and if the discomfort increase it will be performed a possible revision surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that the patient presented to the surgeon due to increase discomfort to her hip where she had a total hip replacement a year ago.An x-ray of her hip shows that the outer metal ring from the r3 constrained liner has broken off.Xray attached.As this outer ring does not affect the locking mechanism of the liner to the cup and the hip is still quite stable, the surgeon decided to leave it as revision surgery may pose bigger risks.The surgeon will continue to monitor closely changing and if the discomfort increase it will be performed a possible revision surgery.The surgeon blames the device.The patient did not suffer any pre-existing conditions that may have contributed to the event.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms based on the documentation provided, there has been no notification of surgical intervention due to the related event.The root cause of the reported event could not be definitively concluded and the fractured ring currently remains in-vivo, as the surgeon felt ¿revision may pose bigger risks¿ and the construct remains ¿quite stable¿.The patient impact beyond the reported increased discomfort and fractured ring could not be determined, as a future surgical procedure may be performed if benefits outweigh the risks.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 for the same failure mode.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 risk management files and instructions for use found that the reported failure was documented appropriately.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique, implant failure or design of device.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.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: 10589307
• Report Number: 1020279-2020-04871
• Device Sequence Number: 3028647
• Product Code: JDI
• UDI-Device Identifier: 03596010597984
• UDI-Public: 03596010597984
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2021

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
• Device Lot Number: 19AM15732
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 08/31/2020; 06/24/2021
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 09/29/2020; 06/28/2021
• 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: Required Intervention