MAUDE Adverse Event Report: ORTHALIGN, INC. IMPACTOR ADAPTER- S/B

Model Number 403028

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hip Fracture (2349); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

The reported inability to disassemble the cup will be investigated once the product is returned. Orthalign is filing this mdr in an abundance of caution due to the outcome of this case and the potential connection to the hipalign system.

Event Description

It was reported that total hip arthroplasty was performed with hipalign. After cup impaction with 48mm cup, the surgeon tried to disengage from cup and impactor. However, he was unable to disassemble the cup. Subsequently, two surgeons disengaged the cup with force. The patient acetabular was little damaged by disassembly so bigger cup (50mm) was used to complete the procedure.

Manufacturer Narrative

Only the impactor adaptor was returned. Upon visual inspection, the threads of the adaptor look to be completely intact. A review of the device history record (dhr) was conducted. The device passed all manufacturing specifications prior to release. Orthalign, inc. Will continue to monitor this issue and take action if alert limits are exceeded.

• Brand Name: IMPACTOR ADAPTER- S/B
• Type of Device: IMPACTOR ADAPTER
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo, ca
• Manufacturer (Section G): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo, ca
• Manufacturer Contact: karyl haskel ; 120 columbia; suite 500; aliso viejo, ca
• MDR Report Key: 10377134
• Report Number: 3007521480-2020-00010
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00858704006565
• UDI-Public: 00858704006565
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 403028
• Device Catalogue Number: 403028
• Device Lot Number: 10808VZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown
• Patient Outcome(s): Required Intervention