MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE); PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number UNKN01102102

Device Problems Biocompatibility (2886); No Apparent Adverse Event (3189)

Patient Problems Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Date 09/20/2020

Event Type  Injury  

Event Description

It was reported that, after left bhr tha on (b)(6) 2008, the plaintiff has suffered of pain, limited mobility, elevated cobalt chromium levels, and debris-filled pseudotumor measuring 6 centimeters.Plaintiff underwent a revision surgery on (b)(6) 2020.The current health status of the patient is unknown.

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, after left bhr tha on (b)(6) 2008, the plaintiff has suffered of pain, limited mobility, elevated cobalt chromium levels, and debris-filled pseudotumor measuring 6 centimeters.Plaintiff underwent a revision surgery on (b)(6) 2020.The current health status of the patient is unknown.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

H6: it was reported that left hip revision surgery was performed.During the revision, the bhr cup, modular head and modular sleeve were all explanted.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.Since part/lot details were not received for investigation no thorough manufacturing record review or assessment of the reported event can be performed.If the products or additional information become available in the future, the tasks will be reopened and performed.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.Modular heads and modular sleeves have been phased out from the market and as a result there is no live risk management file to review.The available medical documents were reviewed.It is unknown if the lateral posterior neck edge impingement on the acetabular cup edge led to accelerated wear and the reported pain, limited mobility, elevated cobalt, and chromium levels, and pseudotumor along with the intraoperative findings of chronic synovitis.Although it was reported the patient had elevated cobalt and chromium levels, neither the levels nor the lab reports were provided for review.Based on the limited information provided, the clinical root cause of the reported clinical reactions cannot be confirmed.It cannot be concluded that the reported clinical reactions were associated with a mal performance of the implant or implant failure.The patient impact beyond revision and expected transient post-operative convalescence period cannot be determined.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.

Event Description

It was reported that, after left bhr tha on (b)(6) 2008, the plaintiff has suffered of pain, limited mobility, elevated cobalt chromium levels, chronic synovitis and debris-filled pseudotumor measuring 6 centimeters.Plaintiff underwent a revision surgery on (b)(6)2020, where the femoral head was replaced for a bh dual mobility insert and a oxinium femoral head.The patient tolerated well the procedure.

• Brand Name: UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE)
• 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: 13014306
• MDR Text Key: 285927122
• Report Number: 3005975929-2021-00570
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01102102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2022
• Was Device Evaluated by Manufacturer?: No
• 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: UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) SLEEVE; UNKN ORTHOPAEDIC RECONSTRUCTION DEV
• Patient Age: 75 YR
• Patient Sex: Male