MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL BALL HEAD 32 XL/+12 CONE; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 75004068

Device Problem Material Deformation (2976)

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

Event Date 04/13/2021

Event Type  malfunction  

Event Description

It was reported that during an inspection, it was noticed that the tabs around the cone of a trial ball head 32 xl/+12 cone were weakened, making the trial not fit well.No case involved.

Manufacturer Narrative

H6: it was reported that during an inspection, it was noticed that the tabs around the cone of a trial ball head 32 xl/+12 cone were weakened, making the trial not fit well.No case involved.The complaint device, intended for use in treatment, was not returned for investigation.The reported issue could not be confirmed.The complaint history review was conducted.The production documentation review could not be performed since the lot number of the complaint device was not provided.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event and the root cause of the reported issue could not be determined conclusively.A relationship between the reported event and the device cannot be confirmed.Should the complaint device and further information become available, the complaint investigation will be reopened.No further actions are deemed necessary at this point.Smith + nephew will continue to monitor for similar issues.

• Brand Name: TRIAL BALL HEAD 32 XL/+12 CONE
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11780342
• MDR Text Key: 249318247
• Report Number: 9613369-2021-00174
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/16/2021

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 Catalogue Number: 75004068
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 05/05/2021
• Supplement Dates Manufacturer Received: 08/16/2021
• Supplement Dates FDA Received: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1