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

Catalog Number 623-00-40F

Device Problems Contamination (1120); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Injury (2348)

Event Date 01/04/2016

Event Type  Injury  

Manufacturer Narrative

Catalog numbers and lot codes of other devices listed in this report: cat.No.: 6260-9-040, v40 cocr lfit head 40mm/-4, lot code: mhn44r.Cat.No.: 6276-1-223, 23mm mod rev hip bdy/blt +20mmcomponent level 9006-1-223, lot code: 28461401.Cat.No.: 6276-7-015, mod con dist stem 15 x 155 mm, lot code: caxl102a.Cat.No.: 2080-0025, gap plate screws, lot code: mjh01y.Cat.No.: 2080-0045, gap plate screws, lot code: mhj289.Cat.No.: 2080-0050, gap plate screws, lot code: mhndp8.At this time, it cannot be determined if these devices may have caused or contributed to the patient¿s experience.Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.Not returned to manufacturer.

Event Description

Subject terminated study (b)(6) 2015 with device in place but on (b)(6) 2016 had a full explant for chronic infection and a spacer implanted on (b)(6) 2016.Additionally on (b)(6) 2015 (patient final visit) the patient had injection for bursitis on the study hip.

Manufacturer Narrative

Concomitant medical products: cat.No.: 509-02-58f, tritanium revision acetabular, lot code: mjj05k.At this time, it cannot be determined if this device may have caused or contributed to the patient¿s experience.An event regarding infection involving a trident liner was reported.The event was confirmed.Method and results: device evaluation and results: a visual, dimensional and functional inspection was not performed as the device was not returned for evaluation.Medical records received and evaluation: review of medical records by a consulting clinician indicated: "there is insufficient documentation presented to complete this assessment.It is unknown if this is the same organism that caused her previous prosthetic infections.Further documentation required would include: operative reports, surgical implant records from the surgeries, microbiology reports, pathology reports, hematology/chemistry reports, outpatient office/clinic notes." device history review: a review of the device history records indicated all devices were manufactured to specifications with no reported discrepancies.Complaint history review: there have been no other events for the lot or sterile lot provided.Conclusions: the exact cause of the reported event could not be determined because insufficient information was provided.Further documentation required would include: operative reports, surgical implant records from the surgeries, microbiology reports, pathology reports, hematology/chemistry reports, outpatient office/clinic notes are needed to investigate this event further.Review of medical records by stryker's (b)(6), advanced quality engineering indicated: the medical records provided do not provide a time line consistent with the narrative and surgeons notes.(b)(6) indicates aspiration alone does not confirm (b)(6).Implant related infection cannot be confirmed.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.If additional information and/or device become available, this investigation will be reopened.

Event Description

Subject terminated study (b)(6) 2015 with device in place but on (b)(6) 2016 had a full explant for chronic infection and a spacer implanted on (b)(6) 2016.Additionally on (b)(6) 2015 (patient final visit) the patient had injection for bursitis on the study hip.

• Brand Name: TRIDENT 0 DEG INSERT 40MM
• Type of Device: 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5606000
• MDR Text Key: 43583615
• Report Number: 0002249697-2016-01332
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 03/29/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: 623-00-40F
• Device Lot Number: MJEDRY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2016
• Initial Date FDA Received: 04/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 60