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

Catalog Number 74120148

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Swelling (2091); Toxicity (2333); Injury (2348); Test Result (2695)

Event Date 02/25/2019

Event Type  Injury  

Event Description

It was reported a right hip revision due to metallosis, pain, fluis collection, pseudotumors, mechanical failure, and elevated test results.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the bhr cup, the hemi head and modular sleeve were removed.The stem remained implanted.As of today, device return and additional information has been requested for this complaint but has not become available.As no device batch numbers were provided for investigation, a manufacturing record review could not be performed.If more information is received, this investigation will be reopened.The available medical documents were reviewed.The intraoperative report indicated 3 large pseudotumors filled with blackish fluid and some bony erosion from the medial aspect of the greater trochanter and medial calcar.The acetabulum itself was well fixed, but noted to have excessive retroversion.The pathology findings were consistent with pseudotumor and alval.It is unknown if the excessive retroversion of the acetabulum led to accelerated wear and metallosis.Although the reported pain, elevated metal ions, intraoperative and pathological finding of pseudotumor and alval are consistent with findings associated with metallosis the root cause cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.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.Additional information: patient identifier, outcomes attributed to adverse event, relevant tests/laboratory data, brand name, and concomitant medical products.

• Brand Name: ACETLR CUP HAP
• 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: 9183976
• MDR Text Key: 162363045
• Report Number: 3005975929-2019-00362
• 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
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

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: Other
• Device Catalogue Number: 74120148
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 09/27/2019
• Supplement Dates FDA Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEMI HEAD 74122542/UNKNOWN; MODULAR SLEEVE 74222100/ UNKNOWN; SYN STEM 71309110/UNKNOWN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 75 YR