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

Model Number	542-11-56F
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Reaction (2414); Ambulation or Postural Difficulties (2544)
Date of Event	05/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a trident shell was reported.The event was not confirmed.Methods & results: product evaluation and results: not performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: b6/13/11 implant labels right hip: 55 trident psl ha cluster shell, 36/0 degrees x3 insert, 4.5 accolade tmzf stem, 36/+5 v40 lfit head.5/6/19 op note: "right total hip revision arthroplasty" p/o diagnosis: ".Catastrophic failure and fracturing of right femoral stem trunnion and disassociation of the head.Loose acetabular socket." ".Significant amount of metallic debris.Trunnion completely worn down to nearly a pencil point.Stem removed with extractor, osteotomes and burr.Acetabulum grossly loose." components revised to 66 titanium acetabulum.0 degree x3 liner.Restoration modular 20/155 stem, 29/30 cone body, 36/-5 biolox head.Uncomplicated surgery.No clinical or pmh, no patient demographics, no primary tha op report, no imaging studies, no laboratory or pathology reports, no examination of explanted components.Based upon the information available for review, no confirmation of the event description or preparation of a medical report is possible for this case.Product history review: indicated 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 lot referenced.Conclusion: no further investigation for this event is possible at this time as no devices and/ or insufficient information was received by stryker orthopaedics.Additional information including operative reports, progress notes, x-rays, imaging studies, laboratory or pathology reports and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Device not returned.
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his right hip on or about june 13, 2011 and was revised on may 6, 2019.It is further alleged that he suffered injuries as a result of implantation and explantation of the device(s) at issue, and excessive levels of chromium and cobalt in his blood.Update july 7, 2020: it was reported that "catastrophic failure and fracturing of right femoral stem trunnion and disassociation of the head.Loose acetabular socket." ".Significant amount of metallic debris.Trunnion completely worn down to nearly a pencil point.Stem removed with extractor, osteotomes and burr.Acetabulum grossly loose.

• 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: 10457078
• Report Number: 0002249697-2020-01736
• Device Sequence Number: 3975201
• Product Code: LPH
• UDI-Device Identifier: 07613327037227
• UDI-Public: 07613327037227
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/26/2020

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: 08/31/2015
• Device Model Number: 542-11-56F
• Device Catalogue Number: 542-11-56F
• Device Lot Number: MJE3EP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 08/26/2020
• 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