MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD44MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number 74122544

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

Patient Problems Failure of Implant (1924); Pain (1994); Metal Related Pathology (4530)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

Complaint reference: (b)(4).

Event Description

It was reported that a revision surgery was performed on the patient right hip on (b)(6) 2020.The revision surgery was performed due to pain and elevated cobalt and chromium levels.Among the intraoperative findings there was a large amount of fluid, as well as membrane which required debriding, consistent with an adverse metal reaction requiring revision of the failed right total hip arthroplasty.The preoperative and postoperative diagnosis was metallosis on the right hip.The patient outcome is unknown.

Manufacturer Narrative

H3, h6: it was reported that right hip revision surgery was performed.During the revision, the head, liner and sleeve were removed.The shell, stem, screws and hole cover 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 stem, hemi head, sleeve and r3 liner 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 head, sleeve and liner.However, as the devices 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.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 hemi 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.The available medical documents were reviewed.The clinical information provided, of the reported elevated metal ion levels, the morse taper corrosion, and the osteolysis, may be consistent with a reaction to metal debris or trunnionosis.The source and the root cause of the symptoms, cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.Without return of the actual devices or further information we cannot further investigate the details supplied in this complaint, our investigation remains inconclusive and a definitive root cause cannot be determined.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.D1, d2, d4, d10, g4.

• Brand Name: HEMI HEAD44MM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 11167475
• MDR Text Key: 226772864
• Report Number: 3005975929-2021-00006
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• PMA/PMN Number: K062408
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

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: 07/30/2013
• Device Catalogue Number: 74122544
• Device Lot Number: 08GW18060
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 06/21/2021
• Supplement Dates FDA Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71306115, LOT: 09FM10917; 71332525, LOT: 08GM14211; 71335556, LOT: 08JM05356; 71336500, LOT: 09GM05289; 71336525, LOT: 07JT12459; 74222200, LOT: 08GW17835; UNKN R3 SHELL; UNKN SLEEVED MODULAR; UNKN SYNERGY HIP STEM; UNKN R3 SHELL; UNKN SLEEVED MODULAR; UNKN SYNERGY HIP STEM
• Patient Outcome(s): Hospitalization; Required Intervention