MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 58MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74120158
Medical Device Problem Codes	Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Insufficient Information (4580); High metal ion levels (4847)
Date of Event	02/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).Initial reporter postal code: (b)(6).
Event or Problem Description
(b)(6).It was reported that, after a bhr resurfacing construct had been implanted on the patient's right hip on (b)(6) 2004, the patient experienced unspecified symptoms.A revision surgery was performed on (b)(6) 2021.During this procedure, the acetlr cup hap 58mm w/ imptr and the resurfacing femoral head 50mm were explanted and replaced with a tha construct.The patient's outcome is unknown.
Additional Manufacturer Narrative
It was reported that a right hip revision surgery was performed.During the revision, the bhr cup and resurfacing femoral head was removed.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 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.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.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.Other similar complaints have been identified to involve this batch, 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.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.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 without medical details of the reported issue, failure modes or reason for revision involved in this complaint, a specific risk management review for the devices cannot be performed.If this information becomes available later, the task will be reopened and completed.No clinical/medical documentations available for review.Smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Without the return of the actual devices or further information we cannot further investigate or confirm the reported complaint, or the details supplied in this complaint.The investigation remains inconclusive, and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If the products or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.Section e corrected to reporting attorney.
Event or Problem Description
*italy legal* it was reported that, after a bhr resurfacing construct had been implanted on the patient's right hip on (b)(6) 2004, the patient experienced pseudotumor formation and elevated metal ion levels in blood.A revision surgery was performed on (b)(6) 2021.During this procedure, the acetlr cup hap 58mm w/ imptr was explanted and replaced with a tha construct.The patient's outcome is unknown.
Additional Manufacturer Narrative
Corrected data: b1 (type of event), h6 (health effect - clinical code, medical device problem code).Updated results of investigation: it was reported that a right hip revision surgery was performed.During the revision, the bhr cup and resurfacing femoral head was removed.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 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.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.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.Other similar complaints have been identified to involve this batch, 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.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.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.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.Any identified risks are reduced in severity / occurrence / detection as far as possible.A review of historic capa/nc/pra/hhe/field actions related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.The revision operative note did not note findings consistent with the reported pseudotumor.However with the limited information provided, the clinical root cause of the reported pseudotumor and elevated metal ions cannot be confirmed.It cannot be concluded the reported events were associated with a mal performance of the implant or implant failure.The impact to the patient beyond the reported revision cannot be determined.Without the return of the actual devices or further information we cannot further investigate or confirm the reported complaint, or the details supplied in this complaint.The investigation remains inconclusive, and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If the products or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: ACETLR CUP HAP 58MM W/ IMPTR
• 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: 12681573
• Report Number: 3005975929-2021-00478
• Device Sequence Number: 3991292
• Product Code: NXT
• UDI-Device Identifier: 03596010502605
• UDI-Public: 03596010502605
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2023

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 Model Number: 74120158
• Device Catalogue Number: 74120158
• Device Lot Number: 31075
• 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: 10/04/2021
• Supplement Date Received by Manufacturer: 12/16/2021; 05/30/2023
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 12/16/2021; 05/31/2023
• 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: 62 YR
• Patient Sex: Male