MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6226-2-644
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
This case was reported by the case card of the study (b)(6).The bha was done with centrax bipolar cup, v40 head and accolade 2 stem at (b)(6) 2016 for left side femoral neck fracture.At (b)(6) 2016 the patient had a little pain on the affected side when she was discharged from hospital.And at (b)(6) 2017 the patient died regardless of the bha surgery.
Event or Problem Description
This case was reported by the case card of the study join.The bha was done with centrax bipolar cup, v40 head and accolade 2 stem at (b)(6) 2016 for left side femoral neck fracture.At (b)(6) 2016 the patient had a little pain on the affected side when she was discharged from hospital.And at (b)(6) 2017 the patient died regardless of the bha surgery.
Additional Manufacturer Narrative
An event regarding pain involving a centrax head was reported.The patient was reported to have died after surgery though it was stated that this was not related to the surgery.The event was not confirmed.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: size 5 accolade ii 127 deg; cat# (b)(4); lot# 53531301.26mm -3 v40 taper vit head; cat# (b)(4); lot# 56410104.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: CENTRAX DURATION 26MM X 44MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8889022
• Report Number: 0002249697-2019-02830
• Device Sequence Number: 14206124
• Product Code: JDI
• UDI-Device Identifier: 07613327032178
• UDI-Public: 07613327032178
• Combination Product (Y/N): N
• PMA/510(K) Number: K972792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other,study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2019

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: 02/28/2021
• Device Catalogue Number: 6226-2-644
• Device Lot Number: DY89TK
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 10/10/2019
• 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: Other
• Patient Weight: 29