MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° CROSSFIRE INSERT 32 MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	621-10-32E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.
Event or Problem Description
On (b)(6) 2019, it was comfirmed a armd (adverse reactions to metal debris).On (b)(6) 2020 revision surgery did.It was no tranionosis.
Event or Problem Description
(b)(6) 201, it was confirmed a armd (adverse reactions to metal debris).2020/1/23 revision surgery did.It was no tranionosis.
Additional Manufacturer Narrative
An event regarding fretting and corrosion of metal components involving a trident liner was reported.Conclusion: it was reported the patient suffered from armd (adverse reactions to metal debris).The reported liner is a poly component and not related to metal debris.Visual inspection on the returned device indicated that damage consistent with the explantation process was observed on the proximal surface of the liner.Impression markings consistent with contact against an acetabular shell was observed on the liner.Yellow discoloration consistent with absorption of synovial fluid was observed.Damage on the articulating surface is consistent with burnishing, scratching, and third body indentations.These are common damage modes of uhmwpe.Hip liner "block" access to the joint space and therefore with almost any revision surgery for whatever reason, these components are removed, more so because they are usually modular and removal is easy and straightforward.Based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event.A full investigation is completed on the metal head and the unknown stem within the same pi.No further investigation is required at this time.If information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIDENT 10° CROSSFIRE INSERT 32 MM ID
• 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: 9746615
• Report Number: 0002249697-2020-00378
• Device Sequence Number: 1974543
• Product Code: LPH
• UDI-Device Identifier: 07613327037807
• UDI-Public: 07613327037807
• Combination Product (Y/N): N
• PMA/510(K) Number: K983502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2020

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: 10/31/2013
• Device Model Number: 621-10-32E
• Device Catalogue Number: 621-10-32E
• Device Lot Number: 28388001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 05/11/2020
• 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
• Patient Age: 82 YR