MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 50MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74120150
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	03/12/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
(b)(6).It was reported that, after a primary left bhr resurfacing construct had been implanted on the plaintiff¿s hip on (b)(6) 2008, the plaintiff experienced elevated levels of cobalt and chromium, metal staining and thickening of the soft tissue.A revision surgery was performed on (b)(6) 2020 to treat this adverse event.During the surgery some metal staining of the tissue and some thickening of the soft tissue suggestive of some reaction to debris from the metal bearing surface was found.The plaintiff¿s outcome is unknown.
Additional Manufacturer Narrative
H3, h6: it was reported that a left hip revision surgery was performed.As of today, device return and additional information has been requested for this complaint but has not become available.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, device labelling / ifu, review could not be performed.The devices would have met manufacturing specifications at the time of production.If more information is received, this investigation will be reopened.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.The available medical documents were reviewed.Per the surgical technique, the acetabular component is to be impacted with 15-20 degree of anteversion and 40-45 degree inclination angle.However, the operative report¿s indication that the acetabular component was ¿very anteverted¿.It is unknown if this position of the acetabular component was a migration since implantation and if led to accelerated wear and the reported elevated cobalt and chromium levels, and intraoperative findings of metal staining and thickening of the soft tissue.Although it was reported the patient had elevated cobalt and chromium levels, neither the levels nor the laboratory reports were provided for review.Without the supporting laboratory/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the report clinical reactions cannot be confirmed.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant or implant failure.The patient impact beyond revision and expected transient post-op convalescence period cannot be determined.No further clinical assessment is warranted at this time.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.
Additional Manufacturer Narrative
H010: additional information added in b6,b7, d1, d2, d4 and g4.H11: corrected data in b3.
Additional Manufacturer Narrative
H10.Additional information in d9.Fda recall - z-2746-2015 for 74121142 resurfacing femoral head 42mm lot# 080860; h3, h6.It was reported that a left hip revision surgery was performed due to elevated levels of cobalt and chromium, metal staining and thickening of the soft tissue.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 head and the cup.This will continue to be monitored via routine trending, however it should be noted that this device is no longer sold.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.The 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, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.The available medical documents were reviewed.Per the surgical technique, the acetabular component is to be impacted with 15-20 degree of anteversion and 40-45 degree inclination angle.However, the implantation operative report indicated the acetabular component was impacted at approximately 25 degrees of anteversion and the revision operative report indicated that the acetabular component was ¿very anteverted¿.It is unknown if this position of the acetabular component, as well as the patient¿s aggressive workouts, led to accelerated wear and the reported elevated cobalt and chromium levels, and intraoperative findings of metal staining and thickening of the soft tissue.Based on the information provided, the root cause of the reported elevated metal ion levels and intraoperative findings of metal staining, soft tissue thickening suggestive of some reaction to debris cannot be confirmed.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant or implant failure.The patient impact beyond revision and expected transient post-op convalescence period cannot be determined.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.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 50MM 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: 12701962
• Report Number: 3005975929-2021-00484
• Device Sequence Number: 4103669
• Product Code: NXT
• UDI-Device Identifier: 03596010502568
• UDI-Public: 3596010502568
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/16/2023

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 Expiration Date: 06/30/2012
• Device Catalogue Number: 74120150
• Device Lot Number: 076505
• 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: 10/06/2021
• Supplement Date Received by Manufacturer: 01/26/2022; 05/11/2023; 06/15/2023
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 01/26/2022; 05/17/2023; 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2746-2015
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74121142 / LOT # 080860
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female