MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 50MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120150

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Toxicity (2333); Injury (2348); Osteolysis (2377); Test Result (2695)

Event Date 06/13/2019

Event Type  Injury  

Event Description

It was reported that a right hip revision surgery was performed due to severe pain, and elevated test results, metallosis and increasing osteolysis.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.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.Incorrect batch numbers were provided for the synergy stem and hemi head devices related to this complaint.Using supplied implantation dates, hospital name and implanting surgeon¿s name the device part/lot numbers reportedly involved in the case have been identified as follows: 71309013 04jm17392a synergy stem size 13 74122542 10483 hemi head 42mm a review of the complaint history for the cup / sleeve / head / stem 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 cup, head and stem.Similar complaints have been identified for the sleeve and this 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.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.No medical records have been received.Without supporting medical documentation, a thorough medical assessment cannot be performed.In the event medical/clinical records are received, the clinical task will be re-opened and a thorough assessment will be rendered at that time.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.

Manufacturer Narrative

It was reported that right 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, sleeve and stem 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 cup, hemi head and stem.Similar complaints have been identified for the sleeve.However, as the device is 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.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.Based on the provided information, the reported pain, elevated metal ions, metallosis, osteolysis and intra-operative findings of caseating adverse local tissue reaction and blackening on the trunnion may be consistent with an adverse reaction to metal debris.However, this cannot be confirmed based on the information provided.The patient¿s self-reported ¿once yearly¿ falls may also be a contributing factor.Without complete pre- and post- primary and revision clinical records, and/or the analysis of the explanted components, the root cause of the reported clinical symptoms cannot be confirmed and 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: ACETLR CUP HAP 50MM 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: 9309631
• MDR Text Key: 165978752
• Report Number: 3005975929-2019-00403
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502568
• UDI-Public: 03596010502568
• 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
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/21/2012
• Device Model Number: 74120150
• Device Catalogue Number: 74120150
• Device Lot Number: 71869
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71309013/ SYN POR PLUS STEM SZ 13/ 04JM179392A; 74122542/ HEMI HEAD 42MM/ 104783; 74222200/ MOD SLEEVE PLUS 0MM 12/14/ 07LW14596; 71309013/ SYN POR PLUS STEM SZ 13/ 04JM179392A; 74122542/ HEMI HEAD 42MM/ 104783; 74222200/ MOD SLEEVE PLUS 0MM 12/14/ 07LW14596
• Patient Outcome(s): Hospitalization; Required Intervention