MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 50MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120150

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Pain (1994); Toxicity (2333); Injury (2348)

Event Date 12/10/2012

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to continuous pain and elevated cobalt and chromium levels.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to continuous pain and continually elevated cobalt and chrome levels.During surgery the bhr cup, hemi head and modular sleeve were removed, however synergy stem remained implanted.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 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.The available medical documents were reviewed.According to the provided implant report, the cup was placed in 20° of anteversion and 40° inclination and there was no mention of a lack of implant stability.According to the provided revision report, there was a large amount of slightly cloudy fluid in the capsule, extensive metallosis in the synovium and trochanteric osteolysis.The cup was described as retroverted and came out easily.There was no evidence of boney ingrowth and showed edge-loading occurred.There was wear on the morse taper.No information on the alleged elevated blood metal ions was provided.Without further information, the reason for the edge-loading and loosening remains unclear.Furthermore it remains unclear how they interrelate or relate to the remaining intraoperative findings cannot be determined.Without return of the actual devices or further information we cannot further investigate or conclusively confirm the details supplied in this complaint, however the revision surgeon reported evidence of edge wear on the cup which could indicate that edge loading has occurred.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 50MM 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
• MDR Report Key: 7517660
• MDR Text Key: 108353961
• Report Number: 3005975929-2018-00166
• 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: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2012
• Device Catalogue Number: 74120150
• Device Lot Number: 71862
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EMP 11 STEM 71291102 LOT 07CM03108; EMP11 SLV SM CONE 71291652 LOT 07EAB0019A; FEMORAL HEAD, PART AND LOT # UNKNOWN; HEMI HEAD 74122542 LOT 07DW11520; MODULAR SLEEVE 74222100 LOT 07KW14451; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR