MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	542-11-46D
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	01/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding loosening involving a trident shell was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: no medical records were received for review with a clinical consultant product history review: indicates all devices were manufactured and accepted into final stock on with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.The following devices were also listed in this report: trident 0 deg insert 36mm; cat# 623-00-36d; lot# ja6al9.Delta v-40 ceramic head 36/0; cat#6570-0-136; lot# unknown.6.5 cancellous bone screw 20mm; cat# 2030-6520-1; lot# unknown.Acetabular dome hole plug; cat# 2060-0000-1; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Conclusion: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as operative reports, histopathology reports, serial x-rays, office reports and examination of explanted components are required are required to complete the investigation for confirmation of the event and determining a root cause.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 or Problem Description
Patient presented to clinic with hip pain.Doctor ordered ct scan and cup appeared to be loose.Cup, dome hole plug, screw, liner, and biolox head taken out.Reimplanted trident ii cup.

• Brand Name: TRIDENT PSL HA CLUSTER 46MM
• 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: 8318989
• Report Number: 0002249697-2019-00767
• Device Sequence Number: 11175079
• Product Code: LPH
• UDI-Device Identifier: 04546540240460
• UDI-Public: 04546540240460
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2019

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: 09/30/2022
• Device Catalogue Number: 542-11-46D
• Device Lot Number: 60828903
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2019
• Initial Report FDA Received Date: 02/07/2019
• 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: 53 YR