MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG X3 INSERT 32MM HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 623-00-32D

Device Problems Material Distortion (2977); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

During trident surgery, scratch was noted to trident 0 deg x3 insert 32mm head.The insert head was exchanged with another new one.

Manufacturer Narrative

An event regarding damage involving a trident liner was reported.The event was confirmed by visual inspection.Conclusions: it was reported that during surgery scratch was observed on the trident insert.Visual of the returned device noted that the device was returned in used condition.Device was observed to be damaged on distal rim.Scratch and small dents were observed on the distal rim.A review of the device by the material analysis engineer indicated that damage observed on distal rim of insert.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

During trident surgery, scratch was noted to trident 0 deg x3 insert 32mm head.The insert head was exchanged with another new one.

• Brand Name: TRIDENT 0 DEG X3 INSERT 32MM HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7306376
• MDR Text Key: 101356795
• Report Number: 0002249697-2018-00583
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327039467
• UDI-Public: 07613327039467
• Combination Product (y/n): N
• PMA/PMN Number: K033716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

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 Expiration Date: 01/31/2022
• Device Catalogue Number: 623-00-32D
• Device Lot Number: PT7T8W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 03/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR