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

Catalog Number 74120152

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

Patient Problems Failure of Implant (1924); Tissue Damage (2104); Toxicity (2333); Injury (2348); No Code Available (3191)

Event Date 12/13/2013

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to soft tissue damage and elevated levels of metal ions.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to soft tissue damage and elevated levels of metal ions.During surgery bhr cup and bhr head were removed.As of today, device return and additional information has been requested for this complaint but has not become available.Since no device part and lot details were received for investigation, no thorough manufacturing record review of the devices involved in the reported event can be performed.The available medical documents were reviewed.Review of the provided implantation report indicated no inconsistencies related to the surgical technique, a potential cause or contributing factor for the later revision.According to the provided revision report, the patient had elevated blood metal ions, well-positioned components and an mri showed moderate evidence of soft tissue reaction.During the revision, there was minimal gray synovial proliferation and no abnormal soft tissue reaction and clear yellow fluid in the acetabulum.Based on the provided documents a root cause for the reported findings cannot be determined.A contribution from the contralateral bhr resurfacing to the blood metal ions cannot be excluded.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 bhr cup and head were 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 and head 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 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 further actions are required at this time.The available medical documents were reviewed.Review of the provided implantation report indicated no inconsistencies related to the surgical technique, a potential cause or contributing factor for the later revision.According to the provided revision report, the patient had elevated blood metal ions, well-positioned components and an mri showed moderate evidence of soft tissue reaction.During the revision, there was minimal gray synovial proliferation and no abnormal soft tissue reaction and clear yellow fluid in the acetabulum.Based on the provided documents a root cause for the reported findings cannot be determined.A contribution from the contralateral bhr resurfacing to the blood metal ions cannot be excluded.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: 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6875099
• MDR Text Key: 86558281
• Report Number: 3005975929-2017-00289
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/24/2021

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: 10/31/2013
• Device Catalogue Number: 74120152
• Device Lot Number: 094561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 09/19/2017
• Supplement Dates Manufacturer Received: 09/12/2017; 09/12/2017; 09/12/2017; 12/23/2021
• Supplement Dates FDA Received: 12/01/2017; 07/24/2018; 02/21/2020; 12/24/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/15/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, PART AND LOT # UNKNOWN.; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male