MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG DAA DOUBLE OFFSET ADAPTER LEFT 80/45; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 75102237

Device Problem Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

Complaint reference: (b)(4).

Event Description

It was reported that the handle disengages when impacted.Failure in device was noticed during set up or inspection.The procedure was completed using the same device.No surgical delay or injury to the patient was reported.

Manufacturer Narrative

Additional information in d4, g4, h4, h6.Investigation results: a daa double offset adapter left 80/45 (art.No.75102237 / lot number a58173) was reported because its handle disengages during impaction.The failure of the device was noticed during set up or inspection.The procedure was completed using the same device.No surgical delay or injury to the patient was reported.The complaint device, used in treatment, was returned for investigation.The reported issue could not be confirmed upon visual inspection and functional control.The connection was not damaged and the connection functioned according to the intended use.The complaint history review was performed, one further complaint was found for a device of the same lot number.The production documentation was reviewed, no deviations from the standard manufacturing process was found which could have contributed to the reported issue.Since no device problem was found, no further actions are deemed necessary.Smith+nephew will continue to monitor similar issues.The complaint device will be discarded.

• Brand Name: DAA DOUBLE OFFSET ADAPTER LEFT 80/45
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11396827
• MDR Text Key: 234224118
• Report Number: 9613369-2021-00083
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00885556535424
• UDI-Public: 00885556535424
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75102237
• Device Catalogue Number: 75102237
• Device Lot Number: A58173
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 03/01/2021
• Supplement Dates Manufacturer Received: 04/15/2021
• Supplement Dates FDA Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1