MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122544

Device Problems Corroded (1131); Metal Shedding Debris (1804); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Tissue Damage (2104); Injury (2348); No Known Impact Or Consequence To Patient (2692); Test Result (2695)

Event Date 10/04/2017

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to pain and other complications.Operative notes reportedly described soft tissue damage due to metal debris and corrosion of the femoral head.

Manufacturer Narrative

Brand name amended.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.

Event Description

Acetabular cup retained during revision.

Manufacturer Narrative

It was reported that the right hip revision surgery was performed.During the revision, the head and sleeve was removed.The 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 hemi head, modular sleeve, acetabular cup and the 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 stem.Similar complaints have been identified for the hemi head and the modular sleeve.However, as the device is no longer sold, no action is to be taken.Similar complaints have been identified for the acetabular 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.The modular sleeve, acetabular cup and the stem all the released devices involved met manufacturing specifications at the time of production.Non-conformance was identified for the castings inspection procedure paperwork for the bhr head.However, all supporting documents confirm that this was an acceptable product when released.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.No further actions are required at this time.The available medical documents were reviewed.Based on the information provided, the reported adverse local tissue reaction and periprosthetic osteolysis which resulted in the right hip revision and bone grafting may be consistent with findings associated with metal debris.The provided lab report suggests reactions/events to be corrosion related toxicity, although it was reported that there was no evidence of microscopic damage to the bhr cup.Therefore, it cannot be concluded that the reported clinical reactions/events were associated with a mal-performance of the implant.It should also be noted that the revised head was exchanged to an off-label mdm head, and implanted in the pre-existing bhr shell.The patient impact beyond the right hip revision and post-operative healing.The last documented follow-up visit reported the patient as doing well with no pain.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 44MM
• 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: 7493585
• MDR Text Key: 107559713
• Report Number: 3005975929-2018-00148
• 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: 06/20/2020

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: Health Professional
• Device Expiration Date: 07/01/2013
• Device Catalogue Number: 74122544
• Device Lot Number: 08GW18059
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/08/2018
• Supplement Dates Manufacturer Received: 04/24/2018; 04/24/2018; 06/17/2020
• Supplement Dates FDA Received: 06/04/2018; 08/02/2019; 06/20/2020
• Patient Sequence Number: 1
• Treatment: ACETABULAR CUP, # 74122150, LOT # 09BW21866.; FEMORAL STEM, # 71306114, LOT # 09CM15051A.; FEMORAL STEM, PART AND LOT # UNKNOWN.; HEMI HEAD, PART AND LOT # UNKNOWN.; MODULAR SLEEVE, # 08JW19036, LOT # 08JW19036.; MODULAR SLEEVE, PART AND LOT # UNKNOWN.; FEMORAL STEM, PART AND LOT # UNKNOWN; HEMI HEAD, PART AND LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR