MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 52MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120152

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

Patient Problems Failure of Implant (1924); Pain (1994); Local Reaction (2035); Toxicity (2333)

Event Date 12/06/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery from the left hip was performed due to pain, metallosis, pseudotumor, elevated metal levels and adverse local tissue reaction.This is a bilateral patient, right hip revision was reported on mdr 3005975929-2019-00031.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the hemi head and sleeve were removed.The bhr cup and 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 bhr cup, 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 bhr cup.Similar complaints have been identified for the hemi head and sleeve.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 a result of the reported event.The available medical documents were reviewed.The clinical information provided, of the pain, metallosis, pseudotumour, elevated metal levels (only one set of metal ion levels provided) and adverse local tissue reaction may be consistent with a reaction to metal debris.However, the source cannot be determined with the available documentation.It was noted that the ¿avascular necrosis¿ was present prior to the primary surgeries.It is unknown if the two documented falls contributed to the required revision surgeries.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: ACETLR CUP HAP 52MM W/ IMPTR
• 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: 8282537
• MDR Text Key: 134253457
• Report Number: 3005975929-2019-00032
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502575
• UDI-Public: 03596010502575
• 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
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74120152
• Device Catalogue Number: 74120152
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANTHOLOGY STEM 71356007 LOT UNKNOWN; HEMI HEAD 74122546 LOT UNKNOWN; MODULAR SLEEVE 74222300 LOT UNKNOWN; ANTHOLOGY STEM 71356007 LOT UNKNOWN; HEMI HEAD 74122546 LOT UNKNOWN; MODULAR SLEEVE 74222300 LOT UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR