MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 36MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 623-00-36D

Device Problems Material Erosion (1214); Pitted (1460); Unstable (1667); Unintended Movement (3026)

Patient Problems Fall (1848); Pain (1994); Injury (2348)

Event Date 06/16/2020

Event Type  Injury  

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.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported that the patient's right hip was revised due to subsidence of the femoral stem after a patient fall.Surgeon reported that the implanted stem was too small for the patient's anatomy and that the fall contributed to subsidence.During the revision, pitting was noted on the inner articular surface of the poly liner.The surgeon reported this was likely caused by abrasive material on the femoral head, and would like the liner to be investigated to confirm, and would like the results.The stem, head, and liner were revised.The devices are allegedly available for return.The rep confirmed that no further information will be released by the hospital or surgeon.

Event Description

It was reported that the patient's right hip was revised due to subsidence of the femoral stem after a patient fall.Surgeon reported that the implanted stem was too small for the patient's anatomy and that the fall contributed to subsidence.During the revision, pitting was noted on the inner articular surface of the poly liner.The surgeon reported this was likely caused by abrasive material on the femoral head, and would like the liner to be investigated to confirm, and would like the results.The stem, head, and liner were revised.The devices are allegedly available for return.The rep confirmed that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding wear involving a trident liner was reported.The event was confirmed through material analysis of the returned device.Method & results: -device evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 08 september 2020.This inspection indicated: damage consistent with the explantation process was observed on the rim of the insert.Damage consistent with scratching and third body indentations was observed; these are common damage modes of uhmwpe.A material analysis has been performed.The report concluded: damage consistent with scratching and third body indentations was observed on the articulating surface of the insert.Damage consistent with articulation against hard particulate was observed on the articulating surface of the head.The head was consistent with an alloy and the stem was consistent an alloy which is consistent with their respective drawings.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-clinician review: no medical records were received for review with a clinical consultant.-complaint history review: there have been no other similar events for the reported lot.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Conclusion: a material analysis has been performed.The report concluded: damage consistent with scratching and third body indentations was observed on the articulating surface of the insert.Damage consistent with articulation against hard particulate was observed on the articulating surface of the head.The head was consistent with an alloy and the stem was consistent an alloy which is consistent with their respective drawings.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes and x-rays are required to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: TRIDENT 0 DEG INSERT 36MM
• 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: 10229280
• MDR Text Key: 197588630
• Report Number: 0002249697-2020-01368
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327025309
• UDI-Public: 07613327025309
• Combination Product (y/n): N
• PMA/PMN Number: K062419
• 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: 10/16/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 623-00-36D
• Device Catalogue Number: 623-00-36D
• Device Lot Number: 6Y42N3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 07/03/2020
• Supplement Dates Manufacturer Received: 09/21/2020
• Supplement Dates FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR