MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 48MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74120148
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Necrosis (1971); Metal Related Pathology (4530)
Date of Event	08/30/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
(b)(6) legal.It was reported that after a left bhr tha construct was implanted on (b)(6) 2006, the plaintiff experienced elevated ion levels on blood, and lobulated-like-mass around the implants the left hip consistent with pseudotumor.A revision surgery was performed on (b)(6) 2016 to treat these adverse events.During the surgery brownish liquid, necrotic tissue and trunnions were found.Additionally, significant corrosion at the junction of the head and the femoral neck was also found.Patient outcome is unknown.
Additional Manufacturer Narrative
H3, h6: it was reported that a left 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 and the modular head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for the cup, and modular head.However, as bhr systems of this size are no longer sold, no action is to be taken.A review of the complaint history for the acetabular cup and the modular head was performed 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 for the femoral head.Other similar complaints have been identified for the acetabular cup.However, as bhr systems of this size are no longer sold, no action is to be taken.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.The available medical documents were reviewed.Although the reported elevated metal ions and intraoperative findings of pseudotumor, retro acetabular cyst, necrotic paste, and corrosion may be consistent with findings associated with metal debris and trunnionosis, the clinical root cause cannot be confirmed.It cannot be concluded that the reported clinical reactions were associated with a malperformance of the implant.The patient impact beyond the revision and expected transient post-op convalescence period 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 48MM 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: 12516677
• Report Number: 3005975929-2021-00415
• Device Sequence Number: 5146554
• Product Code: NXT
• UDI-Device Identifier: 03596010502551
• UDI-Public: 3596010502551
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2022

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 Catalogue Number: 74120148
• Device Lot Number: 50370
• 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: 09/01/2021
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 01/24/2022
• 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: 71356102/ANTHOLOGY HO POROUS SZ 2; UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) SLEEVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 52 YR
• Patient Sex: Female