MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR DYSPLASIA CUP 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74120246
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Toxicity (2333)
Date of Event	03/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that left hip revision surgery was performed due to pain and metallosis.
Additional Manufacturer Narrative
This is a legal complaint reporting a revision of a metal on metal hip due to pain and metallosis.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 supplied medical information was reviewed.Based on the provided documents, pain of the left hip started approximately 1.5 years before the revision and approximately 8 years after the implantation.Review of the provided implantation report (2008) indicates that only half of the leg-length discrepancy was restored by the hip replacement and was then noted to be ¿approximately equal¿ 8 years later in a noted x-ray report in 2016.According to the provided reports dated 2 months before the revision, the blood chromium (3.1 g/l, reference: <1.5 g/l) concentration was high with respect to the given reference and blood cobalt was normal (1.1 g/l, reference: <1.9 g/l).It remains unclear whether the measurements were performed in serum or whole blood.Therefore, a comparison to for example the limits from the mhra ((b)(4)) cannot be done.The provide mri report dated 5 months before the revision did not indicate any adverse findings.According to the surgical report of the revision, there was ¿significant amount of inflammatory-like synovitis associate with the hip¿ and no signs of infection (based on intra-operative observations and a mentioned pre-operative aspirate).I was also reported that there were no elevated inflammatory markers found in the synovial fluid sampled.Excised tissue was sent for analysis to investigate a potential metallosis.The corresponding report and any results were not provided.Based on the available documents metallosis cannot be confirmed but only that there was an inflammatory synovitis, and the intra-operative observations did not note other findings consistent with a metallosis reaction.As no x-rays were provided, a potential involvement of the implant position with the reported findings cannot be assessed.The root cause of the patient¿s pain cannot be concluded.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient¿s particular case, our investigation remains inconclusive.No preventative or corrective action has been initiated as a result of this investigation.(b)(4).

• Brand Name: BHR DYSPLASIA CUP 46MM
• 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: 6688881
• Report Number: 3005975929-2017-00195
• Device Sequence Number: 13463598
• Product Code: NXT
• UDI-Device Identifier: 03596010502650
• UDI-Public: 03596010502650
• 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: 2008
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2017

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: 07/31/2010
• Device Catalogue Number: 74120246
• Device Lot Number: 52134
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 06/27/2017
• Initial Report FDA Received Date: 07/06/2017
• Supplement Report FDA Received Date: 10/03/2017
• 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: DYSPLASIA SCREW, # 74500036, LOT # 06AM12134; DYSPLASIA SCREW, # 74500040, LOT # 07HM13544; FEMORAL STEM, # 71357001, LOT # 06AM02717A; HEMI HEAD, # 74122538, LOT # 10686; MODULAR SLEEVE, # 74222100, LOT # 07FW12477
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 33 YR