MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74122546

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Toxicity (2333); Injury (2348); Test Result (2695)

Event Date 06/25/2019

Event Type  Injury  

Event Description

Us legal: it was reported that the patient had a metal on metal hip arthroplasty 13 years ago.Left hip revision surgery was performed due to elevated blood metal ion levels with pseudotumor formation.

Manufacturer Narrative

It was reported that the left hip revision surgery was performed.During the revision, hemi head and sleeve were removed.Bhr cup and stem 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 cup, hemi head, modular sleeve and anthology stem 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 hemi head, modular sleeve and anthology stem.Similar complaints have been identified for the 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.Device history record review confirmed that all released parts met specifications applicable 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.It should be noted patient was taking cobalt supplements.The elevated metal ions, pseudotumor and trunnionosis may be consistent with findings associated with metal debris; however, without the supporting pathology results and/or the analysis of the explanted components, the root cause of the reported elevated cobalt and chromium levels, pseudotumor and trunnionosis 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 pain, revision, and expected transient post-op convalescence period cannot be determined.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

Additional devices and new part number were added.

Manufacturer Narrative

New information: g4, d4.

• Brand Name: HEMI HEAD 46MM
• 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: 9927018
• MDR Text Key: 186522614
• Report Number: 3005975929-2020-00097
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2011
• Device Model Number: 74122546
• Device Catalogue Number: 74122546
• Device Lot Number: 10244
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71356108 ANTHOLOGY HO PO SZ8 06LM03023.; 71356108, 74120152, 74222300.; 74120152 ACETLR CUP HAP 52MM W/ IM 68475.; 74222300 MOD SLEEVE +4MM 12/14 9637A.
• Patient Outcome(s): Hospitalization; Required Intervention