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

Catalog Number	623-00-44F
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Reaction (2414)
Date of Event	04/30/2019
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.Device evaluation is anticipated but not yet begun.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Patient had revision hip surgery because broken primary stem.Update 06-may-2019: rep provided an operative report for the (b)(6) 2019 revision which cites: "failed left total hip arthroplasty with complete resorption of the trunnion and significant metallosis diffusely about the hip coupled with significantly weak bone secondary to the metallosis polyethylene was removed which had an abnormal color to it secondary to the metallosis significantly worn posteriorly; however, there was no complete loss of polyethylene." rep also provided pre- and post-revision x-rays and reported that no further information will be released by the hospital or surgeon.Update: "black tissue was noted in the patient intra-operatively, pseudo-tumor was reported, no elevated ion levels and there was wear and discoloration of the liner reported".
Additional Manufacturer Narrative
Reported event an event regarding appearance (discolouration) and wear of a trident liner was reported.The discolouration event was confirmed based on the returned device and review of primary and revision operative reports and x-rays provided.The reported wear was not confirmed.Methods and results: -device evaluation and results: a material analysis has been performed.The report concluded: scratching, third body indentations, were observed on the articulating surface of the acetabular insert.The yellow discoloration observed on the insert is consistent with the absorption of synovial fluid.The adhered material on the liner was consistent with material transfer from the stem.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-clinician review: a review of the provided primary and revision operative reports and x-rays dated (b)(6) 2019 by a clinical consultant indicated: on (b)(6) 2019 ¿a left total hip arthroplasty revision¿ was performed for a diagnosis of ¿failed left total hip arthroplasty¿.The operative report describes general anesthesia and a posterolateral approach.The report further notes "poly removed ¿ abnormal color ¿ secondary to the metallosis".-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: material analysis of the returned device has concluded that the scratching, third body indentations, were observed on the articulating surface of the acetabular insert.The yellow discoloration observed on the insert is consistent with the absorption of synovial fluid.The adhered material on the liner was consistent with material transfer from the stem.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.A review of the provided operative reports and x-rays by a clinical consultant indicated: on (b)(6) 2019 ¿a left total hip arthroplasty revision¿ was performed for a diagnosis of ¿failed left total hip arthroplasty¿.The operative report describes general anesthesia and a posterolateral approach.The report further notes "poly removed ¿ abnormal color ¿ secondary to the metallosis".While the yellow discoloration observed on the insert was identified to be consistent with the absorption of synovial fluid, the reported wear was not confirmed.It is noted that explantation damage, scratching, third body indentations, were observed on the articulating surface of the acetabular insert which are common damage modes of uhmwpe.
Event or Problem Description
Patient had revision hip surgery because broken primary stem.Update (b)(6) 2019: rep provided an operative report for the (b)(6) 2019 revision which cites: "failed left total hip arthroplasty with complete resorption of the trunnion and significant metallosis diffusely about the hip coupled with significantly weak bone secondary to the metallosis.Polyethylene was removed which had an abnormal color to it secondary to the metallosis.Significantly worn posteriorly; however, there was no complete loss of polyethylene." rep also provided pre- and post-revision x-rays and reported that no further information will be released by the hospital or surgeon.Update: "black tissue was noted in the patient intra-operatively, pseudo-tumor was reported, no elevated ion levels and there was wear and discoloration of the liner reported.".

• 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
• MDR Report Key: 8647086
• Report Number: 0002249697-2019-02108
• Device Sequence Number: 2211325
• Product Code: LPH
• UDI-Device Identifier: 07613327025422
• UDI-Public: 07613327025422
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K062419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

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: 01/31/2012
• Device Catalogue Number: 623-00-44F
• Device Lot Number: J3KMTA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 08/15/2019
• 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: 70 YR