MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CPCS PRI STD OFFSET 12/14 XSM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71928846
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	08/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, after a thr, a revision surgery was performed in two stages, the first stage on (b)(6) 2021 and the second stage on (b)(6) 2021.In the second stage revision surgery, nine (9) devices were explanted, a ref xlpe all ply cup 36 52, a cocr 12/14 fem head 36mm +8, a cpcs pri std offset 12/14 xsm, a acc std 125mm 5 cbl troch grip, a accord 2.0mm cocr cable, and four (4) acc 2.0mm cocr cables w/clamp.The reason to perform the revision surgery and the patient current health status is unknown.
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, the responses to clinical requests were not provided, therefore, s+n has not received the adequate documentation to fully evaluate the root cause of the reported events.The patient impact beyond the reported event could not be determined based on the limited information provided.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, 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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.No details of the alleged fault, malfunction or injury were provided, therefore no probable cause can be delineated.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: CPCS PRI STD OFFSET 12/14 XSM
• 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: 12516550
• Report Number: 1020279-2021-07081
• Device Sequence Number: 3687583
• Product Code: JDI
• UDI-Device Identifier: 03596010473400
• UDI-Public: 03596010473400
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K823727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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: 71928846
• Device Catalogue Number: 71928846
• Device Lot Number: 19DM00877
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 10/19/2021
• 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; Other