MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 CONST 56MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Model Number	71339156
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Our reference number: (b)(4).
Event or Problem Description
It was reported that the patient had primary thr performed in 2013 and has history of multiple dislocations.The surgeon performed a revision surgery due to disassociation of head and constrained liner, and decided to perform head/liner exchange (however, the femoral head was from a competitor product).The constrained liner was removed (implanted 2017- exact date unavailable) and replaced with new constrained liner.
Additional Manufacturer Narrative
H6: the affected complaint device, used in treatment, was not returned for evaluation.Therefore, a product analysis could not be performed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.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.And failure mode.According to clinical/medical investigation, this case reports that the patient underwent a revision to perform head/liner exchange due to disassociation of the head and constrained liner (femoral head was competitor product).Per reported details, the constrained liner was implanted in 2017, and the patient has history of multiple dislocations.A single undated x-ray was provided and reviewed.Per email correspondence, no additional supporting clinical information will be provided.The x-ray supports the reported event, but no further information can be concluded as to the root cause of the dislocation.Therefore, the patient impact beyond the revision cannot be determined.Due to the limited information provided, no further clinical assessment can be rendered at this time.Should additional clinically relevant documentation become available, the clinical/medical task may be re-opened.Based on this investigation, the need for corrective action is not indicated.A review of risk management files and the instructions for use found that the probable cause failures were documented appropriately.The potential probable causes for this event could include but not limited to a patient condition, user or procedural error.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: R3 CONST 56MM
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11362406
• Report Number: 1020279-2021-01520
• Device Sequence Number: 4069145
• Product Code: KWZ
• UDI-Device Identifier: 00885556020470
• UDI-Public: 00885556020470
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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 Expiration Date: 09/26/2024
• Device Model Number: 71339156
• Device Catalogue Number: 71339156
• Device Lot Number: 14JM20193
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR