MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 64MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74120164
Health Effect - Clinical Codes	Debris, Bone Shedding (1803); Pain (1994); Toxicity (2333); Patient Problem/Medical Problem (2688); Test Result (2695); No Code Available (3191)
Date of Event	06/08/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery from the right hip was performed pain, metallosis trunnionosis, pseudotumor and extensive bone loss.
Additional Manufacturer Narrative
It was reported that right hip revision surgery was performed.During the revision, the bhr cup, hemi head and modular 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 bhr cup, hemi head and sleeve 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 bhr cup and hemi head.Similar complaints have been identified for the sleeve and this failure will continue to be monitored.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 a result of the reported event.The available medical documents were reviewed.The clinical information provided, of the pain, metallosis, a large pseudotumor and extensive bone loss, may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It is unknown what impact the patient¿s congenital bone deformity in their right hip had on the wear of the bhr components.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 64MM
• 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: 8304063
• Report Number: 3005975929-2019-00055
• Device Sequence Number: 16552789
• Product Code: NXT
• UDI-Device Identifier: 03596010502636
• UDI-Public: 03596010502636
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: 2017
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

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: 06/30/2012
• Device Model Number: 74120164
• Device Catalogue Number: 74120164
• Device Lot Number: 076014
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 02/18/2020
• 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 STEM, # 75002704, LOT # E0805918; HEMI HEAD, # 74122558, LOT # 10734; MODULAR SLEEVE, # 74222300, LOT # 07K14074; FEMORAL STEM, # 75002704, LOT # E0805918; HEMI HEAD, # 74122558, LOT # 10734; MODULAR SLEEVE, # 74222300, LOT # 07K14074
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention