MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 38MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number 74122538

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

Patient Problems Pain (1994); Metal Related Pathology (4530); Insufficient Information (4580)

Event Date 08/16/2021

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4).

Event Description

It was reported that, after a thr had been performed on (b)(6) 2011, the patient underwent into a revision surgery, in which the r3 38 mm id us cocr lnr 50 mm and the hemi head 38 mm were explanted.It is unknown if there was an adverse event related to the initial surgery which led to the revision surgery.The current health status of the patient is unknown.

Manufacturer Narrative

H3, h6: it was reported that a left hip revision surgery was performed.During the revision, the r3 liner, modular sleeve and the hemi head were removed.The r3 shell and the 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 liner, hemi head and sleeve 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 liner and hemi head.Similar complaints have been identified for the sleeve.However, as the sleeve is no longer sold, no action is to be taken.A review of the historical complaint data for the liner, hemi head and sleeve was performed using related reported failures and the part number for the prior 12 months as of the complaint aware date.No other similar complaints have been identified for the sleeve.Similar complaints have been identified for the liner and hemi head.However, as the liner and hemi head are no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.All the released devices involved met manufacturing specifications upon release for distribution.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 and no further actions are required at this time.The available medical documents were reviewed.The reported elevated metal ion levels and intraoperative findings of pseudotumor, moderate erosion and osteolytic defects may be consistent with findings associated with metal debris; however, without the supporting laboratory/pathology results, imaging, and/or the analysis of the explanted components, the source of the clinical reactions cannot be confirmed.It cannot be concluded that the reported events/clinical reactions were associated with a malperformance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Without the return of the actual devices or further information we cannot further investigate or confirm the reported complaint, or the details supplied in this complaint.The investigation remains inconclusive, and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If the products or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: HEMI HEAD 38MM
• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin; austin, TX 78735 ; 5123913905
• MDR Report Key: 12431014
• MDR Text Key: 271912942
• Report Number: 3005975929-2021-00397
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00885556071540
• UDI-Public: 00885556071540
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062408
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2013
• Device Model Number: 74122538
• Device Catalogue Number: 74122538
• Device Lot Number: 08DW16539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 09/06/2021
• Supplement Dates Manufacturer Received: 01/13/2022
• Supplement Dates FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention