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

Catalog Number	74120146
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cyst(s) (1800); Toxicity (2333); Injury (2348); Patient Problem/Medical Problem (2688); No Code Available (3191)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed.Metallosis with pseudocysts and osseous defects in the acetabulum and increased serum concentrations of cobalt and chromium.Devices implanted in 2009.
Event or Problem Description
Revision surgery was performed.The exact date is unknown.
Additional Manufacturer Narrative
It was reported that hip revision surgery was performed due to metallosis with pseudocysts and osseous defects in the acetabulum.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.No medical documents were received for investigation.Therefore no medical assessment can be performed.Should clinical documentation become available, the clinical/medical investigation may be re-evaluated.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: BHR ACETABULAR 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: 8412111
• Report Number: 3005975929-2019-00129
• Device Sequence Number: 18891990
• Product Code: NXT
• UDI-Device Identifier: 03596010502544
• UDI-Public: 03596010502544
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

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: 05/31/2012
• Device Catalogue Number: 74120146
• Device Lot Number: 07EW11841
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 05/23/2019
• 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: FEMORAL HEAD, # 74123140, LOT # 07HW13410; FEMORAL HEAD, # 74123140, LOT # 07HW13410
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR