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

Catalog Number 74121146

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Necrosis (1971); Swelling (2091); Toxicity (2333)

Event Date 03/18/2015

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to elevated metal ion levels, necrotic tissue, pseudotumor and metallosis.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due elevated metal ion levels, necrotic tissue, pseudotumor, and metallosis.During the revision the bhr head was removed.The bhr cup remained implanted, a competitor stem, femoral head and dual mobility liner were implanted.As of today, device return and additional information has been requested for this complaint but has not become available.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.The available medical documents were reviewed.This 65 year old male underwent a revision ~ 4 years post implantation of a left bhr.The surgeon indicated that he was also a bhr recipient himself, and is therefore requesting all of his patients with a bhr implant to have metal testing for cobalt and chromium serum levels.The operative report indicated that patient's blood test for cobalt and chrome levels were very high, in addition to developing metallosis.A lab report dated ~2 months pre-revision indicates the plasma chromium level was 31.0 ug/l; no cobalt level was provided.A post-revision lab report (~7 months) indicates a cobalt level of 1.8 ug/l, and chromium level of 6.4 ug/l.It was noted intraoperatively that the patient has recurvatum of the left knee, and probable posterior cruciate insufficiency which was chronic.Neither supporting intra-op findings/images nor pathology results were provided to confirm the reported metallosis.The clinical symptoms of the reported elevated cobalt/chrome levels, necrotic tissue, osteolysis, stained fluid, pseudotumors, and hip pain may be consistent with an adverse reaction to metal debris, but this cannot be confirmed based on the information provided.The source of the elevated metal ions cannot be determined.The future impact to the patient beyond the revision cannot be concluded.No further clinical assessment is warranted at this time.It was also noted that use of a competitor's (stryker) stem, femoral head and dual mobility liner (stryker) these were implanted at the time of revision.This activity was performed contrary to the instructions for use of for bhr implants which states under its important medical information's, "do not mix components from other manufacturers." 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.

• Brand Name: RESURFACING FEMORAL 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: markus poettker ; aarau 5001 ; SZ 5001
• MDR Report Key: 7024079
• MDR Text Key: 91777575
• Report Number: 3005975929-2017-00393
• 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: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

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: Health Professional
• Device Expiration Date: 07/31/2013
• Device Catalogue Number: 74121146
• Device Lot Number: 091289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 11/13/2017
• Supplement Dates Manufacturer Received: 11/07/2017
• Supplement Dates FDA Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/30/2008
• 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: FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR