MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	542-11-58G
Medical Device Problem Codes	Crack (1135); Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); Reaction (2414); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other 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 or Problem Description
It was reported that the patient's right hip was revised after patient complaint of pain.Intra- operatively, black tissue and ceramic fragments were noted, and no ceramic was inside of the alumina insert.The shell, 2 screws, alumina liner and alumina head were revised.Rep provided a primary operative report and implant sheet, pre-revision x-rays, and explant pictures.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a trident shell reported.Conclusions: it was reported that patient was revised due to pain.The review of the provided medical records by clinical consultant state that: the x-rays include an ap and lateral the right hip.They demonstrate an uncemented right tha with 2 screws in the acetabular shell, with the acetabular and femoral components well fixed and nominally positioned.An alumina head is reduced into the acetabular component but is eccentrically migrated superiorly and several radio-dense fragments are noted adjacent to the joint.This is consistent with the description of a fragmented, alumina, acetabular insert".Need revision operative reports, office/clinical reports, serial x-rays, etc.Based on the provided information the product reported in this investigation did not contribute to the event and is therefore considered concomitant.As this case refer to crack/fracture between liner and head so shell not contributed to failure.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's right hip was revised after patient complaint of pain.Intra- operatively, black tissue and ceramic fragments were noted, and no ceramic was inside of the alumina insert.The shell, 2 screws, alumina liner and alumina head were revised.Rep provided a primary operative report and implant sheet, pre-revision x-rays, and explant pictures.

• Brand Name: TRIDENT PSL HA CLUSTER 58MM
• 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: 8727913
• Report Number: 0002249697-2019-02355
• Device Sequence Number: 1685737
• Product Code: LPH
• UDI-Device Identifier: 07613327037319
• UDI-Public: 07613327037319
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2019

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: 07/31/2009
• Device Catalogue Number: 542-11-58G
• Device Lot Number: 17147801
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 09/23/2019
• 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: 60 YR