MAUDE Adverse Event Report: THEKEN COMPANIES INSITU TOTAL HIP SYSTEM; TOTAL HIP ARTHROPLASTY

Model Number OP0450

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

Of the 10 impactors shipped 10/9/2020 by orthogroup, this is the third straight threaded impactor that had broken distal tips upon impact.The event on (b)(6) 2021 was the only one that caused a significant delay in surgery.Although these instruments are designed and manufactured primarily by orthogroup, nextstep is evaluating these impactors to try and replicate the issue.There is significant suspicion that improper assembly of the cup onto the impactor (not fully seated) is contributing to the breakage, as there is evidence of wear on the bow-tie edges that are intended to seat in provided detents.

Event Description

The straight threaded impactor was threaded into the acetabular cup and the surgeon manually manipulated it in place.Upon impacting with a standard mallet, the distal threaded tip of the impactor broke off in two pieces.The larger piece was removed by the patient but the smaller piece was behind the cup and the surgeon opted to leave it in.The event caused a delay in surgery.

• Brand Name: INSITU TOTAL HIP SYSTEM
• Type of Device: TOTAL HIP ARTHROPLASTY
• Manufacturer (Section D): THEKEN COMPANIES; 1800 triplett blvd.; akron OH 44306
• Manufacturer Contact: garrett spurgeon ; 1800 triplett blvd.; akron, OH 44306 ; 3307337600
• MDR Report Key: 12174650
• MDR Text Key: 263619805
• Report Number: 3002498892-2021-00005
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K161184
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial
• Report Date: 07/15/2021

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 Model Number: OP0450
• Device Catalogue Number: 10-95-2067
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 07/15/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR