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 Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Infiltration into Tissue (1931); Muscle Weakness (1967); Ambulation Difficulties (2544); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 01/24/2011

Event Type  Injury  

Event Description

(b)(6) bilateral patient.It was reported that, after bhr construct had been implanted on (b)(6) 2011 on the left hip, high levels of co cr were found in blood, rising up to co: 24.7 mcg/l and cr: 23.5 mcg/l.The x-ray showed edema of the periprosthetic bone tissue, signs of atrophy of the muscle of the buttock and the left piriformis.On (b)(6) 2018, a dysmetria of the lower limbs equal to 5mm was detected in the patient.A revision surgery has not been performed yet.

Manufacturer Narrative

It was reported that, after a bhr construct had been implanted on a patients left hip, it was found that a high level of co cr was in blood.The devices, which were used in treatment, remain implanted in the patient and therefore cannot be evaluated.Additional information has been requested for this complaint but has not become available.A review of the complaint history for the bhr head, modular sleeve and 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 for the cup.Similar complaints were identified for the head & this will continue to be monitored.Similar complaints were identified for the sleeve.However, as the devices are no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Device history record review confirmed that all released parts met specifications applicable at the time of production.The conical stem manufacturing details were reviewed and confirmed.No abnormalities were found.The clinical investigation was reopened due to laboratory levels being provided for review.The newly submitted laboratory results have been reviewed and do not change the conclusion drawn in the previous medical investigation report.Based on the limited information provided the clinical root cause of the reported events cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implants.The patient impact beyond the reported symptoms 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.Due to insufficient information provided we are unable to determine specific factors known to contribute to the alleged fault.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.Section e corrected.

• 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 warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 12400321
• MDR Text Key: 272922638
• Report Number: 3005975929-2021-00389
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502575
• UDI-Public: 3596010502575
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2013
• Device Catalogue Number: 74120152
• Device Lot Number: 091190
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR