MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 38MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74122538
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Nerve Damage (1979); Synovitis (2094); Osteolysis (2377); Metal Related Pathology (4530)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
*us legal* it was reported that a revision surgery was performed on the patient¿s right hip on (b)(6) 2020 due to elevated ion levels and metallosis.The cup, liner and head were removed and exchanged with competitor devices.The stem remained implanted.The patient outcome is unknown.
Additional Manufacturer Narrative
It was reported that right hip revision surgery was performed.During the revision, the r3 shell, r3 liner, hemi head and sleeve were removed.The stem remained implanted.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 r3 shell, r3 liner, hemi head, sleeve and stem 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 r3 shell, r3 liner, hemi head and stem.Similar complaints have been identified for the 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 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 operative reports, the reported elevated metal ions and metallosis may be consistent with findings associated with metal debris.Without supporting radiographic images, lab/pathology reports and/or the analysis of the explanted components, the source of the reported findings cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.Additionally, the clinical root cause of the reported peroneal nerve palsy cannot be concluded.The known patient impact is limited to the revision, the peroneal nerve palsy, the wound exploration and sciatic nerve lysis.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.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.
Additional Manufacturer Narrative
H3, h6: this case was re-opened due to additional medical information becoming available.It was reported that right hip revision surgery was performed.During the revision, the r3 shell, r3 liner, hemi head and sleeve were removed.The stem remained implanted.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 r3 shell, r3 liner, hemi head, sleeve and stem 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 r3 shell, r3 liner, hemi head and stem.Similar complaints have been identified for the 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 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.The reported elevated metal ions and intraoperative findings of metallosis may be consistent with findings associated with metal debris.Without supporting radiographic images, and/or the analysis of the explanted components, the source of the reported findings cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a malperformance of the implant.Additionally, the clinical root cause of the reported peroneal nerve palsy cannot be concluded.The known patient impact is limited to the revision, the peroneal nerve palsy, the wound exploration and sciatic nerve lysis.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, our investigation remains inconclusive and a definitive root cause cannot be determined.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 38MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 11580483
• Report Number: 3005975929-2021-00171
• Device Sequence Number: 4767556
• Product Code: NXT
• UDI-Device Identifier: 00885556071540
• UDI-Public: 885556071540
• Combination Product (Y/N): N
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2021

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: 12/31/2013
• Device Catalogue Number: 74122538
• Device Lot Number: 08MW20389
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 04/01/2021; 05/14/2021
• Initial Report FDA Received Date: 03/28/2021
• Supplement Report FDA Received Date: 04/14/2021; 05/14/2021
• 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; Required Intervention
• Patient Age: 75 YR