MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL SOLID BACK SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 500-11-48D

Device Problem Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2018

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.

Event Description

Nurse informed that the inside of the shell has a scratch.Customer used another shell.

Manufacturer Narrative

Corrected data: - expiration date.Additional information: - gtin; product available to stryker.An event regarding appearance issue involving a trident shell was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection -- a visual inspection was performed on the returned device noted that no scratches were present on the inside or outside of the device.Dimensional inspection: not performed as reported event is not related to the dimensional integrity of the device.Functional inspection: not performed as reported event is not related to device function.Material analysis: not performed as reported event is not related to material integrity.Medical records received and evaluation: a medical review was not performed because no medical information was provided.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the event could not be confirmed.There were no scratches present on the returned device.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Nurse informed that the inside of the shell has a scratch.Customer used another shell.

• Brand Name: TRIDENT HEMISPHERICAL SOLID BACK SHELL
• 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: 7442547
• MDR Text Key: 105918732
• Report Number: 0002249697-2018-01165
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540431844
• UDI-Public: 04546540431844
• Combination Product (y/n): N
• PMA/PMN Number: K143085
• 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: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 500-11-48D
• Device Lot Number: 62811401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Date Manufacturer Received: 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other