MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	623-00-44G
Medical Device Problem Codes	Material Erosion (1214); Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Ambulation or Postural Difficulties (2544)
Date of Event	10/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's left hip was revised due to trunnion wear and head dissociation.Intra-operatively, it was discovered the trunnion dug through the liner and was articulating against the shell, causing additional wear.Metallosis was also noted.The stem, head, and liner were revised.Rep can provide pictures, and confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
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 device not returned.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation of the metal head from the accolade stem and wear (metallosis) involving a trident liner was reported.Conclusion: based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event and is therefore considered concomitant.Visual inspection of the returned device indicated that it is severely damaged on the rim.Damage is consistent with articulation against the severely worn stem.Metallosis is the abnormal buildup and deposition of metallic debris into the periprosthetic soft tissues and adjacent bone from the weight-bearing surface of metal on metal joint replacements.The trident liner is not a metal device and hence cannot contribute to metallosis.A full investigation is completed on the accolade stem and metal head.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
It was reported that the patient's left hip was revised due to trunnion wear and head dissociation.Intra-operatively, it was discovered the trunnion dug through the liner and was articulating against the shell, causing additional wear.Metallosis was also noted.The stem, head, and liner were revised.Rep can provide pictures, and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: TRIDENT 0 DEG INSERT 44MM
• 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: 15805913
• Report Number: 0002249697-2022-01647
• Device Sequence Number: 17510732
• Product Code: LPH
• UDI-Device Identifier: 07613327025385
• UDI-Public: 07613327025385
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K062419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2023

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: 03/31/2016
• Device Model Number: 623-00-44G
• Device Catalogue Number: 623-00-44G
• Device Lot Number: MKEL10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2011
• 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: 75 YR
• Patient Sex: Male