MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 52/58; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74122158

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 03/07/2012

Event Type  Injury  

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the bhr cup was removed.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 was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.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.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 and no further actions are required at this time.

the available medical documents were reviewed.The second stage of the revision noted no evidence of purulence and leukocyte esterase enzyme test was negative.Stryker components implanted.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.

Event Description

It was reported that the patient underwent a medical revision surgery on (b)(6) 2012 on the right hip.The revision was performed due to an infection.The acetabular cup was removed.No s&n implants remain inside the patient right hip.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the bhr cup was removed.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 was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.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.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 and no further actions are required at this time.The available medical documents were reviewed.The second stage of the revision noted no evidence of purulence and leukocyte esterase enzyme test was negative.Stryker components implanted.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.

• Brand Name: ACETABULAR CUP HAP SIZE 52/58
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 10691401
• MDR Text Key: 211711337
• Report Number: 3005975929-2020-00387
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552310
• UDI-Public: 03596010552310
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 10/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2012
• Device Model Number: 74122158
• Device Catalogue Number: 74122158
• Device Lot Number: 07HW12975
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 10/12/2020
• Supplement Dates FDA Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention