MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	542-11-56F
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	03/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.
Event or Problem Description
Right total hip replacement washout & implant exchange for infection.Original thr: (b)(6) 2019.Tissue specimens sent to pathology for analysis at time of surgery.
Additional Manufacturer Narrative
Corrected data: device information corrected.Catalog numbers and lot codes of other devices listed in this report: cat:623-10-32f description: trident 10° x3 insert 32mm id lot: p287nh, cat:6720-0635 description: size 6 accolade ii 132 deg lot: 67267002, cat:6260-9-232 description: 32mm +4 lfit v40 head lot: 59253404.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An event regarding infection and loosening involving a trident shell was reported.The event was not confirmed.Method & results -product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted trident shell with blood and tissue on it which is consistent with newly explanted device.Nothing remarkable to report.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.There have been no other similar events for the sterile lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Right total hip replacement washout & implant exchange for infection.Original thr: (b)(6) 2019.Tissue specimens sent to pathology for analysis at time of surgery.Update: revision rthr for infection.Hip washout & implants exchanged.Femoral head from original surgery reused.Acetabular cup replaced due to loosening when removing liner.

• Brand Name: TRIDENT PSL HA CLUSTER 56MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8480447
• Report Number: 0002249697-2019-01526
• Device Sequence Number: 1839610
• Product Code: LPH
• UDI-Device Identifier: 07613327039863
• UDI-Public: 07613327039863
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

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: 10/30/2023
• Device Catalogue Number: 542-11-56F
• Device Lot Number: 1K5AEM
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 05/23/2019
• 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: 62 YR
• Patient Weight: 120