MAUDE Adverse Event Report: SMITH AND NEPHEW ORTHOPAEDICS LTD HEMI HEAD 42MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number 74122542

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Metal Related Pathology (4530)

Event Date 07/07/2020

Event Type  Injury  

Event Description

It was reported that a revision hip surgery was performed on (b)(6) 2020 due to elevated hip effusion.Also, serum cobalt blood work report showed elevated cobalt and chromium level.The modular metal head, the sleeve and the r3 metal liner were explanted.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

It was reported that hip revision surgery was performed.During the revision, the liner, head and sleeve removed.The stem, spout, screws and shell 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 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 head.Similar complaints have been identified for the liner and sleeve.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.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.Based on the clinical reports of elevated cobalt and the effusion, these may be consistent with a reaction to metal debris.The provided images do not contribute to the root cause of the reported revision.However, the source and the root cause cannot be determined with the available documentation.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.Due to insufficient information provided we are unable to determine specific factors known to contribute to the alleged fault.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

Corrected information in: d10: the concomitant devices list was updated.The modular sleeve {} plus 0mm 12/14 / 74222200 / lot: 09aw20999 was added as a concomitant product.Internal reference number: (b)(4).

• Brand Name: HEMI HEAD 42MM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): SMITH AND NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; lemington spa warwickshire TN ; UK
• MDR Report Key: 10347385
• MDR Text Key: 201146669
• Report Number: 1020279-2020-03581
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00885556070710
• UDI-Public: 885556070710
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2013
• Device Catalogue Number: 74122542
• Device Lot Number: 08JW18944
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71291302,71335554,71332515,71332525, 71291665; EMP 13 STEM PRIMARY HO / 71291302 / LOT: 09GM06115; EMP13 SLV MED CONE2 SPOUT / 71291665 / L09AAB0041A; MODULAR SLEEVE {} PLUS / 74222200 / LOT: 09AW20999; R3 3 HOLE ACET SHELL / 71335554 / LOT: 09KM07878; REF SPHER HEAD SCREW / 71332515 / LOT: 09ET31805; REF SPHER HEAD SCREW / 71332525 / LOT: 09JT35189
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR