MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 54MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120154

Device Problems Fracture (1260); Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 08/25/2016

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to failure aseptic loosening of the cup, pseudotumor formation, acetabular fracture and disassociation.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the bhr cup, hemi head and modular sleeve were removed.The echelon primary 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 devices reportedly involved in this incident.The available medical documents were reviewed.These findings may be consistent with an adverse reaction to metal debris; however, without patient medical history, supporting lab/pathology results, imaging to confirm the reported cup loosening, acetabular fracture/disassociation, and/or the analysis of the explanted components, the source cannot be confirmed and it cannot be concluded that the reported intraoperative reports of ¿metallosis¿ are associated with a malperformance of the implant.However, the reported trunnionosis and aseptic cup loosening could not be ruled out as contributing factors to the reported events.All the released devices involved met manufacturing specifications at the time of production.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.Further, it cannot be concluded that the reported clinical reactions were associated with a malperformance 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 54MM 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, CV313 HL; UK CV313HL
• MDR Report Key: 7873107
• MDR Text Key: 120158684
• Report Number: 3005975929-2018-00316
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502582
• UDI-Public: 03596010502582
• 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: 10/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74120154
• Device Lot Number: 080043
• Date Manufacturer Received: 08/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71341022/ECH PRI FEM COMP HO SZ 12/07HM19354; 74122546/HEMI HEAD 46MM/07DW11423; 74222200/ODULAR SLEEVE {} PLUS 0MM 12/14/07LW14555; 71341022/ECH PRI FEM COMP HO SZ 12/07HM19354; 74122546/HEMI HEAD 46MM/07DW11423; 74222200/ODULAR SLEEVE {} PLUS 0MM 12/14/07LW14555
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR