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
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint reference: (b)(4).
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9613369-2021-00083
• Device Sequence Number: 3286258
• Product Code: JDI
• UDI-Device Identifier: 00885556535424
• UDI-Public: 00885556535424
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 75102237
• Device Catalogue Number: 75102237
• Device Lot Number: A58173
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1