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 Rash (2033); Vertigo (2134); Toxicity (2333); No Code Available (3191)

Event Date 11/16/2012

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed.Pseudotumour, rash, vertigo and metallosis reported.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to pseudotumour, rash, vertigo and metallosis reported.During surgery bhr head and bhr cup were removed.As of today, device return and additional information has been requested for this complaint but has not become available.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.The available medical documents were reviewed.Patient with a history of right hip oa who received a bhr tha 10 years ago, underwent a revision approximately 4.5 years post implantation.The revision operative report states that the patient did well with the right bhr implant from "a pain point of view" however developed swelling of the anterior hip.The report also states that an mri demonstrated a large pseudotumor emanating from the hip.An extensive synovectomy was performed demonstrating a large amount of metal-stained synovial tissue.The pseudotumor was excised and the specimen was sent for frozen section, however there are no reported results provided.It was indicated that the patient was seen by an allergist who noted no evidence of metal allergy.There is a lab report provided (dated 4/18/2017) which indicates that the patient's serum cobalt and blood chromium values are within the normal range.No radiographic images or explanted devices have been provided.It is unclear whether the reported findings correspond to an increased amount of wear on the bearing surfaces of the implants, as the devices are not available for analysis and no radiographic images have been provided.However the root cause of the revised bhr devices is related to the pseudotumor, although the definitive source causing the pseudotumor is unknown.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: 7056693
• MDR Text Key: 92836329
• Report Number: 3005975929-2017-00408
• 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: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

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: 07/31/2012
• Device Catalogue Number: 74120152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2017
• Initial Date FDA Received: 11/23/2017
• Supplement Dates Manufacturer Received: 11/17/2017
• Supplement Dates FDA Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/26/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR