MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122552

Device Problems Noise, Audible (3273); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Pain (1994); Discomfort (2330); Injury (2348)

Event Date 01/04/2012

Event Type  Injury  

Event Description

It was reported a left hip revision due to persistent pain and discomfort in his hips and heard it popping on numerous occasions.Head explanted.Stryker components implanted.

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 has been requested for this complaint but has not become available.A review of the complaint history for the head & sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other complaints have been identified for the head.Similar complaints were 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 known devices reportedly involved in this incident.Device history record review confirmed that all released parts met specifications applicable at the time of production.It was also confirmed that all known devices were sterilised.Review of the product ifu for the head & sleeve found adequate warnings and precautions in relation to the alleged failure modes.Without the definitive part numbers of the cup, the manufacturing review, complaint history review and the specific product labelling and ifus for the devices cannot be reviewed.If this information becomes available at a later time, the tasks will be reopened and completed.A risk management review was performed.No additional risks were identified as result of the reported event.No further actions are required at this time.The medical documents were reviewed.The purulent-appearing cloudy fluid, synovitis and fibrinous exudate may be consistent with findings associated with infection; however, the origin of the infection is highly likely of an exogenous nature and there is no evidence that our product contributed to the infection.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.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.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 head & sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other complaints have been identified for the head.Similar complaints have been identified for the sleeve however, as the device is no longer sold, no action is to be taken.Without definitive part/lot numbers for the cup a complete complaint history review cannot be performed.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.Device history record review confirmed that all released parts met specifications applicable at the time of production.It was also confirmed that all devices were sterilised.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 further actions are required at this time.The medical records were reviewed.The purulent-appearing cloudy fluid, synovitis and fibrinous exudate may be consistent with findings associated with infection; however, the origin of the infection is highly likely of an exogenous nature and there is no evidence that our product contributed to the infection.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.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

New information: g4, d4.

• Brand Name: HEMI HEAD 52MM
• 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: 9532633
• MDR Text Key: 173108829
• Report Number: 3005975929-2019-00465
• 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: other,user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/22/2015
• Device Catalogue Number: 74122552
• Device Lot Number: 09CW16130
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2020
• Patient Sequence Number: 1
• Treatment: 74122158 ACETABULAR CUP HAP SIZE 52/58; 74222100 MOD SLEEVE -4MM 12/14 08CW16007