MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 60MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120160

Device Problem Biocompatibility (2886)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Inadequate Osseointegration (2646); Metal Related Pathology (4530)

Event Date 09/09/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case-(b)(4).

Event Description

*us legal mdl* it was reported that, after a primary bhr resurfacing construct had been implanted on the plaintiff¿s right hip on (b)(6) 2007, the plaintiff experienced pain, limited mobility and elevated metal ion levels.A revision surgery was performed on (b)(6) 2019 to treat this adverse event.The plaintiff¿s outcome is unknown.

Manufacturer Narrative

Additional information: a2, a3, b5, d1, d4, h6.

Event Description

*us legal mdl* it was reported that, after a primary bhr resurfacing construct had been implanted on the plaintiff¿s right hip on (b)(6) 2007, the plaintiff experienced pain, limited mobility, loosening of the femoral head, and elevated metal ion levels.A revision surgery was performed on (b)(6) 2019 to treat this adverse event.During the surgery the femoral head was explanted.The plaintiff¿s outcome is unknown.

Manufacturer Narrative

Additional information: d4, h4.H3, h6: it was reported that right hip revision surgery was performed.During the revision femoral head was explanted.The acetabular cup remained implanted.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 cup and head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the head.Other similar complaints have been identified for the cup and this will continue to be monitored.A review of the historical complaint data for the cup and head 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 were identified.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 known devices 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.Any identified risks are reduced in severity / occurrence / detection as far as possible.The available medical documents were reviewed.The reported elevated metal ions and clinical information provided, of dramatic cystic changes of the femoral neck and loosening of the femoral component, may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.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 60MM 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: 12497599
• MDR Text Key: 272217536
• Report Number: 3005975929-2021-00411
• Device Sequence Number: 1
• Product Code: NXT
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2012
• Device Catalogue Number: 74120160
• Device Lot Number: 076011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/25/2007
• 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
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 54 YR
• Patient Sex: Male