MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122550

Device Problems Improper or Incorrect Procedure or Method (2017); Appropriate Term/Code Not Available (3191)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 09/09/2015

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to metallosis.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the hemi head, modular sleeve and anthology stem were removed.The bhr dysplasia cup, 40mm screw, 60mm screw and zimmer tantalum acetabular augment remained 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.The available medical documents were reviewed.The implantation operative report indicated a zimmer tantalum augment was used over the s&n dysplasia acetabular shell for acetabular deficiency over the posterior superior wall.Per the complaint, the revising surgeon reportedly described metallosis, elevated cobalt and chromium levels in his operative report; however, there was no specific mention of metallosis in the received operative report.The revision operative report noted that a clinical workup had ruled out infectious etiology.It was also noted that there were no signs of loosening or wear.It cannot be determined to what extent the patients¿ comorbidities and third party hardware had on his pain and clinical status.Without the supporting lab/pathology results and/or the analysis of the explanted components, the root cause of the reported elevated cobalt and chromium levels, found intraoperatively cannot be confirmed.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.It was noted that use of a competitor¿s (zimmer) tantalum acetabular augment was implanted with the bhr dysplasia cup.Further, it was noted that use of a competitor¿s (stryker) ceramic head, polyethylene head, modular stem and trochanteric grip plates were implanted with the bhr dysplasia cup at the time of revision.Both of these activities were performed contrary to the instructions for use of for bhr implants which states under its important medical information, ¿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: HEMI HEAD 50MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, CV313 HL; UK CV313HL
• MDR Report Key: 7881081
• MDR Text Key: 120415265
• Report Number: 3005975929-2018-00314
• 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: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2013
• Device Catalogue Number: 74122550
• Device Lot Number: 08KW19430
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANTHOLOGY STEM 71357010/10FM12013A; DYSPL CUP 58MM 74120258/067056; MODULAR SLEEVE 74222200/10BW25770; SCREW 40 MM 74500040/06AM12135; SCREW 60 MM 74500060/07HM13548; UNKNOWN BHR IMPLANT/ UNKNOWN LOT NUMBER; UNKNOWN BHR IMPLANT/ UNKNOWN LOT NUMBER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR