MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 40MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	623-00-40F
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	10/03/2019
Type of Reportable Event	Serious Injury
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 left hip on or about (b)(6) 2006 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 at issue, device recall and excessive levels of chromium and cobalt in his blood.Update 05-oct-2022 mf: per provided medical records: "the hip did in fact have trunnionosis and there was a moderate amount of blackish material at the femoral neck/head junction and, however, the trunnion for the most part was still grossly intact and structurally intact [.] when the stem was checked for rotational stability, there were bubbles and fluid coming out of the proximal interface between the femoral stem and the bone and this obviously was indicative of a femoral of a fibrous interface and there was aseptic loosening present.[.] the acetabular component was completely well fixed and did not have evidence of osteolysis or erosion, but the polyethylene did have slight yellowish color due to what appeared to be some early oxidation and there was also some scratching of the polyethylene." there were no reported allegations against the shell, and it was revised to a competitor device.
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a trident liner was reported.The event was not confirmed.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.

• Brand Name: TRIDENT 0 DEG INSERT 40MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 15672126
• Report Number: 0002249697-2022-01549
• Device Sequence Number: 6462249
• Product Code: LPH
• UDI-Device Identifier: 07613327025316
• UDI-Public: 07613327025316
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2022

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: 08/31/2011
• Device Model Number: 623-00-40F
• Device Catalogue Number: 623-00-40F
• Device Lot Number: JR4MMA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2006
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male