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

Catalog Number 74120148

Device Problem Biocompatibility (2886)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 01/20/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after left bhr-tha surgery was performed on (b)(6) 2009, the patient experienced pain at the hip joint and elevated cobalt and chromium levels.This adverse event was treated with revision surgery on (b)(6) 2021.During this procedure, the bhr modular head was removed from the system and replaced with a smith and nephew dual mobility liner and a 28mm +4 oxinium head.Intraoperatively, the acetabular component was noted to be in good position and without any evidence of loosening.The trunnion presented a small amount of corrosion in the mid distal region but was overall in good shape.The patient was transferred to the post anesthesia care unit without any complications.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.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 acetabular cup, hemi head and sleeve 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 of acetabular cup and hemi head.Other similar complaints were identified to involve this batch of sleeve.Other similar complaints have been identified for the part number of acetabular cup and hemi head and the reported failure mode, and this failure will continue to be monitored.No other similar complaints were identified for the part number and the reported/related failure mode for the sleeve.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¿ 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 required.The available medical documents were reviewed.Although it was reported that the revision surgery was performed secondary to pain and elevated cobalt and chromium, neither the levels nor the lab reports were provided for the review.It should be noted the surgical technique for bhr (01/07 4567-0103) indicates, the acetabular component is to be fully impacted with 15-20° of anteversion and 40-45° inclination angle.It is unknown if the increased anteversion of the acetabular component led to accelerated wear and the reported pain, elevated cobalt and chromium, and small amount of corrosion on the trunnion.It cannot be concluded that the reported clinical reactions were associated with a mal performance of the implant.The patient impact beyond the pain, revision and expected convalescence period cannot be determined.Based on the information provided we cannot confirm or further investigate the reported complaint, our investigation remains inconclusive, and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, excessive patient weight, trauma to the joint replacement.Should the devices or additional information be received, the complaint will be reopened.Based on the investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: ACETLR CUP HAP 48MM W/ IMPTR
• Type of Device: 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: 14633971
• MDR Text Key: 293564404
• Report Number: 3005975929-2022-00386
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502551
• UDI-Public: 3596010502551
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2013
• Device Catalogue Number: 74120148
• Device Lot Number: 083916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/08/2022
• Supplement Dates Manufacturer Received: 08/23/2022
• Supplement Dates FDA Received: 08/23/2022
• Date Device Manufactured: 02/28/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ANTHOLOGY HO POR PL HA SZ 5, LOT#:09BM17828A.; MODULAR SLEEVE +4MM 12/14, LOT#:08JW19038.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female