MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 52/58; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74120156
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Infiltration into Tissue (1931); Pain (1994); Metal Related Pathology (4530)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case- (b)(4).
Event or Problem Description
Us legal.It was reported that, after a right bhr had been performed on (b)(6) 2011, plaintiff experienced hip pain and loss of function also it has presented elevated cobalt ions.A revision surgery was performed on (b)(6) 2019 to treat the adverse events.Patient outcome is unknown.
Additional Manufacturer Narrative
H3, h6: it was reported that right hip revision surgery was performed.During the revision, the femoral head was explanted.The acetabular cup remained implanted.As of today, the explanted devices, all of which were used in treatment have not been returned for evaluation.A review of the historical complaints data for the acetabular cup was performed.Using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.Other similar complaints were identified to involve this batch and for the part number and the reported failure mode, and this failure will continue to be monitored.A review of the historical complaints data for the femoral head was performed.Using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.No other similar complaints were identified to involve this batch.Other similar complaints have been identified for the part number and the reported failure mode, and this failure will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.All the 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.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions required.The available medical documents were reviewed.Per the surgical technique, the acetabular component is to be impacted with 15-20° of anteversion and 40-45° inclination angle.However, the implantation operative report indicated the acetabular component was implanted at 20-25° and abduction of 35 degrees it is unknown if the increased anteversion and abduction of the acetabular component led to accelerated wear and the metal-stained synovium and tissue, and pseudocapsule noted intraoperatively.¿cobalt toxicity¿ was reported; however, neither the levels nor the lab reports were provided.With the information provided the clinical root cause of the reported clinical findings cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Based on the information provided we cannot confirm or further investigate the reported complaint, 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, improper selection, placement, positioning, and fixation of the implant components may result in early implant failure.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.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Additional Manufacturer Narrative
H3, h6: it was reported that right hip revision surgery was performed.During the revision, the femoral head was explanted.The acetabular cup remained implanted.As of today, the explanted devices, all of which were used in treatment have not been returned for evaluation.A review of the historical complaints data for the acetabular cup was performed.Using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.Other similar complaints were identified to involve this batch and for the part number and the reported failure mode, and this failure will continue to be monitored.A review of the historical complaints data for the femoral head was performed.Using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.No other similar complaints were identified to involve this batch.Other similar complaints have been identified for the part number and the reported failure mode, and this failure will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.All the 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.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions required.The available medical documents were reviewed.Per the surgical technique, the acetabular component is to be impacted with 15-20° of anteversion and 40-45° inclination angle.However, the implantation operative report indicated the acetabular component was implanted at 20-25° and abduction of 35 degrees it is unknown if the increased anteversion and abduction of the acetabular component led to accelerated wear and the metal-stained synovium and tissue, and pseudocapsule noted intraoperatively.¿cobalt toxicity¿ was reported; however, neither the levels nor the lab reports were provided.With the information provided the clinical root cause of the reported clinical findings cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Based on the information provided we cannot confirm or further investigate the reported complaint, 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, improper selection, placement, positioning, and fixation of the implant components may result in early implant failure.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: ACETABULAR CUP HAP SIZE 52/58
• Common Device Name: PROSTHESIS, 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: 12778778
• Report Number: 3005975929-2021-00511
• Device Sequence Number: 11655693
• Product Code: NXT
• UDI-Device Identifier: 03596010552310
• UDI-Public: 03596010552310
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/21/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2015
• Device Model Number: 74120156
• Device Catalogue Number: 74122158
• Device Lot Number: 10LW30828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 03/15/2022; 03/16/2022; 03/16/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 03/15/2022; 03/17/2022; 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2010
• 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: 46 YR
• Patient Sex: Male