MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABLR CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Discomfort (2330); Toxicity (2333)

Event Date 12/30/2008

Event Type  Injury  

Event Description

It was reported that a right bhr revision surgery was performed due to persistent pain and discomfort.Also metal ion levels tested and discovered that the level of cobalt in the patient's system is significantly elevated.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the head was removed.The 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 bhr head and bhr cup 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 bhr head.Similar complaints have been identified for the bhr 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 devices reportedly involved in this incident.All the 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 and no further actions are required at this time.The available medical documents were reviewed.Patient had a right resurfacing six weeks post implantation the surgeon noted ¿x-rays (b)(6) 2008 were suspicious for femoral neck fracture¿ on (b)(6) 2008 she had a conversion to tha.The revision intraoperative report indicated motion was apparent at the head neck junction.Without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported fracture cannot be confirmed, and it cannot be concluded that the reported event was associated with a malperformance of the implant.The patient impact beyond the pain, revision and expected transient post-op convalescence period cannot be determined.

• Brand Name: ACETABLR CUP
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 9955644
• MDR Text Key: 187509172
• Report Number: 3005975929-2020-00106
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2020
• Initial Date FDA Received: 04/13/2020
• Supplement Dates Manufacturer Received: 10/01/2020
• Supplement Dates FDA Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention