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

Catalog Number 75100855

Device Problem Misassembled (1398)

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

Event Date 08/29/2018

Event Type  Injury  

Event Description

It was reported that during trialling the femoral heads on the actual prosthesis, both the -3 global head trial and the s and m plus head trials dissociated from the neck both during the shuck test, as well as the 90deg external rotation stability test.This meant the surgeon could not ascertain the hip stability, requiring an intraoperative x-ray to ascertain leg length and offset.Adding 45 minuets to the operation.The outcome of the patient was positive.No injury was caused.

Manufacturer Narrative

Additional info: a complaint was reported due to the disconnection of a global trial femoral head during trialing.No part was returned for investigation.No medical documents were received for investigation.Therefore no medical assessment can be performed.Similar connection issues have been reported for the global trial femoral heads.Further investigations have attributed the root cause of the issue to insufficient design specifications.Improvements of the design of this instrument are ongoing.

• Brand Name: TRIAL FEMORAL HEAD 36 XS/-3
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar, 06340 ; SZ 06340
• MDR Report Key: 7975857
• MDR Text Key: 124064625
• Report Number: 9613369-2018-00063
• Device Sequence Number: 1
• Product Code: LZO
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 75100855
• Device Lot Number: A54115
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/29/2018
• Initial Date FDA Received: 10/17/2018
• Supplement Dates Manufacturer Received: 08/29/2018
• Supplement Dates FDA Received: 11/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PN: 75100480 / LOT: B1715646; PN:75100480 LN:B1715646 POLARSTEM LAT.TI/HA 7
• Patient Outcome(s): Other