MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 62MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120162

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

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 07/07/2009

Event Type  Injury  

Event Description

It was reported that a revision surgery from the left hip was performed to ceramic-on-poly possibly due to oversized bhr cup.

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 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 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.It should be noted that the implantation intraoperative report noted reaming to 61 and placement of 62mm bhr acetabular cup.However, the revision intra-operative report indicated that the 62mm smith and nephew acetabular component was extracted.The acetabulum was then deepened and reamed to a 58-mm diameter, with a 58-mm trabecular metal acetabular component pressed into place, which may be inconsistent with the devices reportedly used.The mva as well as the radiological and intra-operative findings of the over-sized head and mal-positioned acetabular cannot be ruled out as contributing factors to the reported failed acetabular component.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.

• Brand Name: ACETLR CUP HAP 62MM 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: 8551583
• MDR Text Key: 143115345
• Report Number: 3005975929-2019-00178
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502629
• UDI-Public: 03596010502629
• 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: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2010
• Device Catalogue Number: 74120162
• Device Lot Number: 54260R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEMI HEAD 54MM 74122554 LOT 10262; SLEEVE -4MM 12/14 74222100 LOT 07EW11730; SYN STEM SZ 15 71309115 LOT 07FM07881A; HEMI HEAD 54MM 74122554 LOT 10262; SLEEVE -4MM 12/14 74222100 LOT 07EW11730; SYN STEM SZ 15 71309115 LOT 07FM07881A
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR