MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA RADIAL HEAD - 24MM

Catalog Number 221424

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint device was not returned for evaluation.The dhr for pn: 221424, lot: kv0101 was reviewed.The lot size was 111 units.Records shows that a sample of 20 parts underwent dimensional inspection, all of which were within specification.No nonconformances were generated associated with this lot.Possible root cause include user error (mismatch between stem and head sizing), damage induced during surgery, or user interface.However, based on the information to date, the root cause for the event is unknown.

Event Description

It was reported that the during the coupling of the katalyst radial head (pn: 221424, lot: kv0101) and stem intra-operatively on (b)(6) 2019, the poly on the implant initially gave greater resistance to coupling than is customary.After multiple attempts to couple the implants, this implant finally coupled with the stem, but did not have the audible popping sound that is usually heard by the surgeon and was used as an indication that the interface interacted as expected.The surgeon suspected that this may indicate that the tolerances of the poly were not as designed.This item was removed from the patient and another implant with a different lot number was implanted without issue.

• Brand Name: RADIAL HEAD - 24MM
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: vivian nelson ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8601829
• MDR Text Key: 147620176
• Report Number: 1651501-2019-00017
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: K032806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 221424
• Device Lot Number: KV0101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1