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

Model Number 75102240

Device Problems Connection Problem (2900); Premature Separation (4045)

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

Event Date 05/11/2021

Event Type  malfunction  

Event Description

It was reported that the daa double offset adapter right 80/45 is not locking tight enough onto the broach and the spring feels loose.It is unknown when the event happened and if there was a patient involved.

Manufacturer Narrative

(b)(4).H6: medical device problem code changed.

Manufacturer Narrative

H3, h6: it was reported that the daa double offset adapter right 80/45 is not locking tight enough onto the broach and the spring feels loose.The device, intended for use in treatment, was not returned for investigation.A product evaluation could therefore not be performed.Nevertheless, the batch number was reported and the production documentation review was performed.No additional complaint with batch: a61360 was reported so far.A review of the production documentation for the batch in scope did not reveal any deviation from the standard operating procedure.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Based on the performed investigations, a relationship between the reported event and the device cannot be confirmed and the root cause of the reported problem remains unknown.The need for corrective action is not indicated.Normal wear and tear through repeated is known to contribute to the reported event.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all devices must be inspected and controlled for proper functioning after cleaning/disinfection.Smith and nephew will continue to monitor the device for similar issues.Apart from that, no further actions are deemed necessary at the time.This investigation is considered closed.The complaint will be reopened should the device be received.

• Brand Name: DAA DOUBLE OFFSET ADAPTER RIGHT 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: 11891043
• MDR Text Key: 252993999
• Report Number: 9613369-2021-00267
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00885556535394
• UDI-Public: 00885556535394
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2021

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: 75102240
• Device Catalogue Number: 75102240
• Device Lot Number: A61360
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 05/26/2021
• Supplement Dates Manufacturer Received: 05/11/2021; 07/19/2021
• Supplement Dates FDA Received: 07/19/2021; 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1