MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71335558

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Tissue Breakdown (2681); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 05/16/2018

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

''(b)(6) legal'': it was reported that, after an r3-tha construct had been implanted on the plaintiff¿s left hip on (b)(6) 2012, the plaintiff experienced metallosis with the presence of an alval lesion, weakness, pain, swelling and pseudotumor formation.A revision surgery was performed on (b)(6) 2018 to treat this adverse event.The 46mm diameter bhr modular head, r3 acetabular liner co-cr and r3 58mm three hole hemispherical stiktite shell were explanted.The plaintiff was taken to recovery room in stable condition.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.The devices, used in this treatment, were not returned for evaluation and additional information has been requested for this complaint but has not become available.A review of the complaint history for the modular head, r3 liner, r3 shell, modular sleeve and stem was performed using the batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the modular head, r3 shell and stem.Similar complaints have been identified for the r3 liner and sleeve.However, as the devices are no longer sold, no action is to be taken.On account of the fact devices reportedly involved in this incident were not returned for evaluation, the relevant production records were reviewed.All released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.No further actions are required at this time.The available medical documents were reviewed.It cannot be determined to what extent the patient¿s history of paget's disease had on his bone stock, the implantation angles of the acetabulum, if the devices migrated and the clinical status.Although the reported aseptic lymphocyte-dominant vasculitis-associated lesion, necrosis and pseudotumor may be consistent with findings associated with metal debris; the clinical root cause of the reported clinical reactions 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 revision and expected transient post-op convalescence period cannot be determined.Without the return of the actual product involved or product information, our investigation could not proceed and remains inconclusive.A definitive root cause cannot be determined, and we are unable to determine specific factors known to contribute to the alleged fault.Should the device or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.No further investigation is warranted for this complaint.

• Brand Name: R3 3 HOLE ACET SHELL 58MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12519937
• MDR Text Key: 272934074
• Report Number: 1020279-2021-07096
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598271
• UDI-Public: 03596010598271
• Combination Product (y/n): N
• PMA/PMN Number: K070756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2019
• Device Model Number: 71335558
• Device Catalogue Number: 71335558
• Device Lot Number: 09FM19539A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 78 YR