MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 42MM; PROSTHESIS, HIP, SMI-CNSTRIND, MTL/MTL, RESURFACING

Model Number	74122542
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); No Code Available (3191)
Date of Event	11/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a right hip revision surgery due to a severe failure of the right total hip arthroplasty, advance alval (pseudotumor, aseptic lymphocytic vasculitic-associated lesion).
Additional Manufacturer Narrative
A1, b3 and d7 corrected.
Additional Manufacturer Narrative
It was reported that right hip revision surgery was performed.During the revision, all smith & nephew devices were removed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the acetabular shell, threaded hole cover, hemi head modular sleeve, r3 liner, 30mm screw, 25mm screw and 20mm screw was performed using batch numbers in search of similar recurring reports for the products during their lifetimes no other similar complaints were identified for the acetabular shell, r3 liner, 30mm screw, 25mm screw and 20mm.Similar complaints have been identified for the hemi head and sleeve.However, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The available medical documents were reviewed.Based on the provided information, the reported intra-operative findings of alval type fluid and cyst may be consistent with and adverse reaction to metal debris but this cannot be confirmed based on the limited information provided.However, the surgeon did indicate that the acetabular component was ¿grossly malpositioned¿ vertical and overanteverted¿ which may also be a contributing factor.Without supporting post-primary radiographic images, lab/pathology results, and/or the analysis of the explanted components, the root cause of the reported clinical symptoms cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the revision and associated post-op pain cannot be determined, and the patient is reported as doing very well.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.Based on the available information, the suggested root cause is improper loading due to the vertical and over-anteverted acetabular component.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: HEMI HEAD 42MM
• Common Device Name: PROSTHESIS, HIP, SMI-CNSTRIND, MTL/MTL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 9930145
• Report Number: 3005975929-2020-00096
• Device Sequence Number: 2733029
• Product Code: NXT
• UDI-Device Identifier: 00885556070710
• UDI-Public: 00885556070710
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2020

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: 74122542
• Device Catalogue Number: 74122542
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/07/2020
• Supplement Date Received by Manufacturer: 07/20/2020; 09/08/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 07/21/2020; 09/08/2020
• 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: 71332520 REF SPHER HEAD SCREW 20MM 07LT14483; 71332525 REF SPHER HEAD SCREW 25MM 07KT13708; 71332530 REF SPHER HEAD SCREW 30MM 08GT21549; 71335554R3 3 HOLE ACET SHELL 54MM 09CM15477; 71336500 REF THREADED HOLE COVER 08JM06254; 71341154 R3 42MM ID US COCR LNR 54MM 0BNW20853; 74222200 MODULAR S PLUS 0MM 12/14 OBCW16015; 71332520 REF SPHER HEAD SCREW 20MM 07LT14483; 71332525 REF SPHER HEAD SCREW 25MM 07KT13708; 71332530 REF SPHER HEAD SCREW 30MM 08GT21549; 71335554R3 3 HOLE ACET SHELL 54MM 09CM15477; 71336500 REF THREADED HOLE COVER 08JM06254; 71341154 R3 42MM ID US COCR LNR 54MM 0BNW20853; 74222200 MODULAR S PLUS 0MM 12/14 OBCW16015
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR