MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD 48MM HEMI HEAD; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 74122548

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

Patient Problems Pain (1994); Injury (2348); No Code Available (3191)

Event Date 08/28/2018

Event Type  Injury  

Event Description

Revision surgery was performed.

Event Description

It was reported that a 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 and modular sleeve were removed.The bhr cup and anthology stem 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 indicates the cup was impacted into place in approximately 4 degrees of cup abduction and 20 degrees of cup anteversion.However, the revision operative report indicated the cup position appeared to be very satisfactory in approximately 10-15° of forward flexion and 40-45° of abduction.It is suspected the abduction angle noted in the implantation operative report was a typo, but without the implantation and pre-revision x-rays to determine initial implant anatomical placement, this cannot be ruled out as a contributory factor to the reported issue.The surgical technique notes that the acetabular component should be impacted with 15-20 degrees of anteversion and 40-45 degrees of inclination.The revision operative report indicated there was 50% pre-collapse of the right hip.Although the patient¿s medications included those which may have affected bone quality, a radiology report showed the patient¿s bone density to be normal approximately 1 ½ months prior to revision.Fibrinous debris and dark staining material of the lining of the pseudocapsule and capsule were noted to have been found during revision.The reported elevated cobalt/chromium levels and intraoperative findings of the fibrinous/dark debris and stained material of the lining of the pseudocapsule are consistent with findings associated with metallosis; however, the root cause of the reported elevated cobalt and chromium levels, metallosis, pain, and limited mobility 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.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

Brand name, common device name & model amended to reflect updated case information.Smith & nephew is submitting this report pursuant to the provisions of 21cfr, part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.

• Brand Name: 48MM HEMI HEAD
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 7892789
• MDR Text Key: 120824548
• Report Number: 3005975929-2018-00325
• Device Sequence Number: 1
• Product Code: JDH
• UDI-Device Identifier: 03596010502582
• UDI-Public: 03596010502582
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Catalogue Number: 74122548
• Device Lot Number: 08FW17377
• Date Manufacturer Received: 08/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETABULAR CUP, # 74120154, LOT # UNKNOWN; FEMORAL STEM, # 71357010, LOT # UNKNOWN; HEMI HEAD, # 74122548, LOT # UNKNOWN; MODULAR SLEEVE, # 74222100, LOT # UNKNOWN; PART#: 71357010, LOT#: 08BM09320A; PART#: 74120154, LOT#: 08EW17229; PART#: 74222100, LOT#: 08AW15248; FEMORAL STEM, # 71357010, LOT # UNKNOWN; HEMI HEAD, # 74122548, LOT # UNKNOWN; MODULAR SLEEVE, # 74222100, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR