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 Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Unequal Limb Length (4534)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, after a right bhr tha surgery had been performed on (b)(6) 2009 due to avascular necrosis, the plaintiff experienced elevated metal ion levels, trunnionosis, right hip pain and right leg length discrepancy.Patient underwent a revision surgery on the right hip on (b)(6) 2021 to treat these adverse events, where the head was explanted and replaced with an oxinium femoral head and a dual mobility liner.The current health status of the patient is unknown.
Additional Manufacturer Narrative
H3, h6: it was reported that a right hip revision surgery was performed.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 acetabular cup, hemi head and sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Other similar complaints were identified for the acetabular cup, hemi head and sleeve.This failure will continue to be monitored in the case of the acetabular cup.However, as the hemi head and sleeve are no longer sold, no action is to be taken.A review of the historical complaint data for the acetabular cup, hemi head and sleeve was performed using related reported failures and the part number for the prior 12 months as of the complaint aware date.No other similar complaints have been identified for the sleeve.Similar complaints have been identified for the acetabular cup and hemi head.However, as the hemi head is no longer sold, no action is to be taken.This failure will continue to be monitored in the case of the acetabular cup.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.A risk management review was performed for the acetabular cup.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.Hemi heads/ sleeves have been phased out from the market and as a result there is no live risk management file to review.Therefore, an evaluation of failure modes is not required.The available medical documents were reviewed.The reported pain, elevated metal ions and intraoperative findings of corrosion at the head-neck taper and the stem-trunnion may be consistent with findings associated with metal debris.However, the root cause of the reported clinical findings cannot be confirmed, but based on the intraoperative findings of corrosion, trunnionosis is a likely source.It cannot be concluded that the reported clinical reactions were associated with a mal performance of the implants.Without the return of the devices used in treatment or additional information we cannot advance the investigation or confirm this complaint; our investigation remains inconclusive, and a definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.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 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: 13101488
• Report Number: 3005975929-2021-00592
• Device Sequence Number: 4696501
• Product Code: NXT
• UDI-Device Identifier: 03596010502605
• UDI-Public: 03596010502605
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2022

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 Expiration Date: 06/30/2013
• Device Model Number: 74120158
• Device Catalogue Number: 74120158
• Device Lot Number: 090127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 03/07/2022
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71306117/SYN POR HO FEM COM SZ 17; 74222300/MODULAR SLEEVE +4MM 12/14
• Patient Age: 59 YR
• Patient Sex: Male