MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG CONSTRAINED INSERT 32H; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	690-00-32H
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Arthritis (1723); Pain (1994); Injury (2348)
Date of Event	10/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Device not returned.
Event or Problem Description
It was reported that the patient's left hip was revised due to pain.Examination notes provided by the rep indicate the following: "excruciating pain in the hip region when he tries to stand from a seated position and particularly when he tries to get in and out of a car¿began experiencing pain in the left foot.I think he is developing impingement creating a polyethylene synovitis." a 32 +0 biolox c-taper head and sleeve, and size h trident constrained liner were revised to a 28 +0 biolox c-taper head and 28 mm size h constrained liner.Rep provided operative reports, usage sheets, exam notes, and an mri report and reported that no further information will be released by the hospital or surgeon.
Event or Problem Description
It was reported that the patient's left hip was revised due to pain.Examination notes provided by the rep indicate the following: "excruciating pain in the hip region when he tries to stand from a seated position and particularly when he tries to get in and out of a car¿began experiencing pain in the left foot.I think he is developing impingement creating a polyethylene synovitis." a 32 +0 biolox c-taper head and sleeve, and size h trident constrained liner were revised to a 28 +0 biolox c-taper head and 28mm size h constrained liner.Rep provided operative reports, usage sheets, exam notes, and an mri report and reported that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
An event regarding patient factors involving a trident insert was reported. the event was confirmed by a review of the provided medical records by a clinical consultant.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: -clinician review: a review of the provided medical records by a clinical consultant indicated: narrative {.} reportedly he did well following this surgery but a year later he developed pain in his left foot.He was evaluated and no foot pathology was identified.He was then evaluated by a neurologist and an emg was performed confirming chronic sciatic neuropathy.A mars mri was performed which showed a large fluid collection which had extravasated through destroyed tissue and impinged upon his sciatic nerve.In addition the fluid extravasated anteroinferiorly surrounding the psoas tendon.The tendon which appeared torn and there was marked psoas atrophy.These findings were reviewed with patient on (b)(6) and a second revision surgery was planned.This surgery occurred on (b)(6) 2019.No operative note was available for review however the implant record from this procedure indicates the constrained liner was revised to another constrained liner and ane new ceramic head and liner placed as well.{.} -device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the pain was determined to be ' a large fluid collection which had extravasated through destroyed tissue and impinged upon his sciatic nerve.'.

• Brand Name: TRIDENT 0 DEG CONSTRAINED INSERT 32H
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9335713
• Report Number: 0002249697-2019-03801
• Device Sequence Number: 11244715
• Product Code: KWZ
• UDI-Device Identifier: 07613327025569
• UDI-Public: 07613327025569
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 690-00-32H
• Device Lot Number: MMPH83
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 90