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

Catalog Number	623-00-40E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Discharge (2225); Complaint, Ill-Defined (2331); Injury (2348); Reaction (2414)
Date of Event	12/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: hris flexible osteo.12 x 120 mm;cat#:6210-0-710; lot#: x16e37a, hris flexible osteo 12 x 93 mm;cat#:6210-0-740; lot#: x16h33a, v40 cocr lfit head 40 mm/-4;cat#:6260-9-040; lot#:475ady, 23 mm mod rev hip bdy/blt +10 mm component level 9006-1-123;cat#:6276-1-123; lot#:54047002, mod con dist stem 18 x 155 mm; cat#:6276-7-018; lot#: caxp242a.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.
Event or Problem Description
After revision of stem and insert on (b)(6) because due to a disassociated head from stem, patient showed signs of infection and metal colored fluid leaking from incision.All implants were removed.
Additional Manufacturer Narrative
An event regarding infection involving an trident liner was reported.The event was not confirmed.Method & results: device evaluation and results: could not be performed as the subject device was not returned.Medical records received and evaluation: the provided medical information was submitted to a consulting clinician who deemed it insufficient for a medical review.Device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the reported lot and sterile lot.Conclusions: the source of the infection could not be determined as patient information, clinical history, and results of bloodwork for infection were not provided.No further investigation for this event is possible at this time.If devices and/or additional information become available, this investigation will be reopened.A capa trend analysis was conducted for the reported failure mode and concluded infection is most likely a result from other factors not necessarily related to the device in the healthcare facility setting.
Event or Problem Description
After revision of stem and insert on (b)(6) because due to a disassociated head from stem, patient showed signs of infection and metal colored fluid leaking from incision.All implants were removed.

• 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
• MDR Report Key: 6228372
• Report Number: 0002249697-2017-00130
• Device Sequence Number: 13730835
• Product Code: LPH
• UDI-Device Identifier: 07613327025323
• UDI-Public: (01)07613327025323(11)160817(10)210831(10)YP0Y2W
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K062419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2017

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: 08/31/2021
• Device Catalogue Number: 623-00-40E
• Device Lot Number: YP0Y2W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2017
• Supplement Report FDA Received Date: 03/16/2017
• 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: 76 YR
• Patient Weight: 78