MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74122162
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Toxicity (2333)
Date of Event	10/29/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a fracture of the femoral stem at the neck.Elevated metal levels in his blood were also found.
Additional Manufacturer Narrative
It was reported that right hip revision surgery was performed.During the revision, the hemi head, modular sleeve and echelon stem were removed.The bhr cup 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 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.No implantation operative report was provided.Although metal ion levels were reported to be elevated up to 6.0 g/l cobalt: 7.4 g/l and there were intraoperative findings of prosthetic fracture to the neck of the total hip stem, which are consistent with findings associated with metal debris, without the supporting histopathology findings, images or the explant for analysis it cannot be concluded that the clinical reactions are associated with a mal-performance of the implant.The patient impact beyond the pain and revision cannot be determined 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 information: test/laboratory data, brand name, device identification, initial reporter also sent reports to fda and device manufacture date.

• Brand Name: HEMI HEAD 56MM
• 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: 8305372
• Report Number: 3005975929-2019-00050
• Device Sequence Number: 1148087
• Product Code: NXT
• UDI-Device Identifier: 03596010552334
• UDI-Public: 03596010552334
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2019

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: 07/31/2013
• Device Catalogue Number: 74122162
• Device Lot Number: 08CW16490
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 12/12/2019
• 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: ECH FEM COMP 71341016 LOT 07FM21528A.; HEAD 56MM 74122556 LOT 08GW18174.; MODULAR SLEEVE 74222400 LOT 07FW12489.; ECH FEM COMP 71341016 LOT 07FM21528A; HEAD 56MM 74122556 LOT 08GW18174; MODULAR SLEEVE 74222400 LOT 07FW12489
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 52 YR