MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 62MM W/ IMPTR; PROST, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74120162
Medical Device Problem Codes	Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint reference: (b)(4).
Event or Problem Description
It was reported that a revision surgery was performed on (b)(6) 2020 on the patient right hip due to pain and metallosis.The patient outcome is unknown.
Additional Manufacturer Narrative
As of today, device return and additional information has been requested for this complaint but has not become available.Since neither the underlying medical documents nor device part details were received for investigation no thorough medical investigation, manufacturing record review and assessment of the reported event can be performed.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 preventive or corrective action has been initiated as a result of this investigation.
Event or Problem Description
It was reported that a revision surgery was performed on (b)(6) 2020 on the patient right hip due to pain and metallosis.Both metallic components were explanted during the revision surgery.The primary right hip bhr surgery was performed on (b)(6) 2018.
Additional Manufacturer Narrative
It was reported that a right revision surgery was performed due to pain and metallosis.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.A review of the historical complaints data for the devices concerned was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the acetabular cup and the femoral head, this 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.All released devices involved met manufacturing specifications upon release for distribution.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.The available medical documents were reviewed.The reported pain, effusion, and metal staining may be consistent with reported metallosis; however, with the information provided the clinical root cause of the reported metallosis cannot be confirmed.It cannot be concluded the reported clinical reactions were associated with a malperformance of the implant.Based on the available information we can confirm the reported complaint, however without further information our investigation remains inconclusive, and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: ACETLR CUP HAP 62MM W/ IMPTR
• Common Device Name: PROST, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11444176
• Report Number: 3005975929-2021-00130
• Device Sequence Number: 3523417
• Product Code: NXT
• UDI-Device Identifier: 03596010502629
• UDI-Public: 03596010502629
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/28/2022

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 Model Number: 74120162
• Device Catalogue Number: 74120162
• Device Lot Number: 16EW17227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 04/12/2021; 10/07/2022; 10/27/2022
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 04/14/2021; 10/13/2022; 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male