MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122546

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

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

Event Date 07/13/2010

Event Type  Injury  

Event Description

It was reported that bilateral (this side left) hip revision surgery was performed due to unspecified reasons.

Event Description

It was reported that bilateral (this side left) hip revision surgery was performed due to pain, elevated test results and trunnionosis.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the hemi head and modular sleeve removed.The bhr cup and short taper stem remained implanted.As of today, device return and additional information has been requested for this complaint but has not become available.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.The available medical documents were reviewed.Although the reported elevated cobalt & chromium, trunnionosis and pain are consistent with findings associated with metal debris, the root cause of the reported reactions cannot be confirmed.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.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, 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: 8685111
• MDR Text Key: 147558864
• Report Number: 3005975929-2019-00239
• 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
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2013
• Device Catalogue Number: 74122546
• Device Lot Number: 08KW19322
• Date Manufacturer Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETLR CUP HAP 52MM 74120152/093158; FEMORAL HEAD, PART AND LOT # UNKNOWN; MODULAR SLEEVE -4MM 12/14 74222100/08GW17828; SHORT TAPER STEM PC STD SZ 8 71932824/08FM09249
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR