MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 48/56; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74122156
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	04/17/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery of the right hip was performed due to the presence of a pseudotumor.
Additional Manufacturer Narrative
It was reported that right hip revision surgery was performed due to the presence of a pseudotumor.During the revision, the bhr cup, bhr modular head and modular sleeve were removed.The anthology stem remained implanted.As of today, device return and additional information has been requested for this complaint but has not become available.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.The available medical documents were reviewed.This patient underwent a right bhr revision approximately 8 years, 1 month post implantation due to the reported presence of a pseudotumor.Operative reports were provided and translated from french.The revision op report indicates there was a large granuloma, which was removed and revealed corrosion at the head-neck junction.There was also a large medial lesion with significant bone loss at the acetabulum.After extensive debridement, the acetabulum was grafted and the cup was impacted.Cultures were sent to pathology.Stability was tested and was excellent with 50° of internal rotation, at 90° of flexion.Cultures were sent to pathology, however the results were not provided.Without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the source of the reported pseudotumor cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.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.

• Brand Name: ACETABULAR CUP HAP SIZE 48/56
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 8283377
• Report Number: 3005975929-2019-00033
• Device Sequence Number: 1685958
• Product Code: NXT
• UDI-Device Identifier: 03596010552303
• UDI-Public: 03596010552303
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

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: 06/30/2011
• Device Catalogue Number: 74122156
• Device Lot Number: 8728
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 06/12/2019
• 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: ANTHOLOGY STEM 71356104 LOT 05JM03945; MODULAR HEAD 74222148 LOT 10122; MODULAR SLEEVE 74222200 LOT 9766
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention