MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 46MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 74122546

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

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

Event Date 03/22/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to unknown reasons.

Manufacturer Narrative

Brand name,common device name & expiration date corrected to reflect updated event narrative received.

Event Description

It was reported that a revision surgery was performed due to periprosthetic cystic osteolysis.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision the hemi head & modular sleeve were removed.The acetabular cup & stem remained implanted.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.A review of the complaint history for the cup / head / 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 head + cup.Similar complaints have been identified for the sleeve and this failure will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the 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.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 medical documents were reviewed.The clinical information provided, of the elevated metal ion levels and pain may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.The revision operative report did not document any visual signs of a reaction to the metal on metal prosthesis, no ¿osteolysis or particle disease¿ that was stated as the reason for the revision.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 46MM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 8390300
• MDR Text Key: 137819249
• Report Number: 3005975929-2019-00108
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74122546
• Device Lot Number: 11424
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETABULAR CUP, # 74120154, LOT # 07630; FEMORAL STEM, # 71355107, LOT # 07HM04887A; MODULAR SLEEVE, # 74222200, LOT # 07FW11496; UNKNOWN ANTHOLOGY STEM; UNKNOWN BHR HEAD; UNKNOWN ANTHOLOGY STEM; UNKNOWN BHR HEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR