MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 36 XS/-3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number 75100855

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2020

Event Type  malfunction  

Event Description

It was reported that, during tha, the tabs that hold the head on a trunnion have snapped off while trialing.Sn backup was available.No delay was recorded.

Manufacturer Narrative

It was reported that the tabs of a trial femoral head 36 xs/-3 have snapped off while trialing, a s+n backup was available.No delay was recorded.The complaint device, used in treatment, was not returned for investigation.The product evaluation could hence not confirm the reported failure mode.The complaint history review was performed and no other complaint was reported for devices of the same production lot.No deviations were found from the standard operating procedure in the production documentation review.Based on the conducted investigation, the root cause could not be determined conclusively for this complaint.However, previous investigations demonstrated that the trial femoral head may disconnect from the stem taper intra-operatively.In combination with our continuous effort to improve our products, evaluations aimed at optimizing this instrument have been initiated.The performance of the device is nonetheless within the risks, which are anticipated in the risk management documentation of the product, both in occurrence and severity.The continued performance of the device shall be monitored through standard pms review processes.The complaint will be reopened should the part will be returned or should additional information be received.S+n will continue to monitor these devices for similar issues.

• Brand Name: TRIAL FEMORAL HEAD 36 XS/-3
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 9841896
• MDR Text Key: 187023368
• Report Number: 9613369-2020-00069
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07611996121889
• UDI-Public: 07611996121889
• Combination Product (y/n): N
• PMA/PMN Number: K132435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2021

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?: No
• Device Operator: No Information
• Device Model Number: 75100855
• Device Catalogue Number: 75100855
• Device Lot Number: A57531
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 04/24/2020; 03/17/2021
• Supplement Dates FDA Received: 04/28/2020; 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1