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	Bone Fracture(s) (1870); Inflammation (1932); Pain (1994); Injury (2348); Reaction (2414)
Date of Event	06/04/2019
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.Device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: [.] 2/5/07"implant logs" :56 trident psl acetabular shell, 36 trident polyethylene insert, #5 right citation stem, 36/+5 v40 lfit head.(b)(6) 2019 op reports "orif anterior column acetabular fracture" revision right tha diagnosis "failed right tha secondary to catastrophic trunnion failure, pathologic acetabular fracture.With loosening of acetabular component" orif with zimmer plate and screws.Revision tha with smith & nephew revision components and simplex p bone cement.".The taper was heavily damaged.Removed stem with osteotomes and slap hammer.Liner grossly loose in acetabulum.Removed socket with explant device." revised to competitor products and orif greater trochanter fracture.Uncomplicated surgery.No clinical or pmh, no patient demographics, no imaging studies, no primary tha op report, no laboratory or pathology reports, no examination of explanted components.Based upon the information available for review, confirmation of the event description or creation of a medical report is not possible for this case.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: 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.
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 (b)(6) 2007 and was revised on (b)(6) 2019.It is further alleged that he suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood.Update july 31, 2020: clinical consultant's review indicated that there was an acetabular fracture and that the liner was worn.

• 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: 10454008
• Report Number: 0002249697-2020-01719
• Device Sequence Number: 3974582
• Product Code: LPH
• UDI-Device Identifier: 07613327037227
• UDI-Public: 07613327037227
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• 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: 01/31/2012
• Device Model Number: 542-11-56F
• Device Catalogue Number: 542-11-56F
• Device Lot Number: 2H3MAD
• 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