MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 32/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6570-0-132
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Injury (2348); Joint Dislocation (2374)
Date of Event	08/13/2018
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 relevant 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
It was reported through the submission of a revision implant sheet that patient's left hip was revised.Patient originally had an entire stryker hip construct including a 32 +0 ceramic head implanted in (b)(6) 2017.Revision implant sheet only indicates a 32 +4 ceramic head was implanted.
Event or Problem Description
It was reported through the submission of a revision implant sheet that patient's left hip was revised.Patient originally had an entire stryker hip construct including a 32 +0 ceramic head implanted in (b)(6) 2017.Revision implant sheet only indicates a 32 +4 ceramic head was implanted.Update (b)(6) 2018: sales rep stated "the patient had fallen from a ladder and dislocated.She told the surgeon that she continued to dislocate after being popped back in multiple times.The surgeon decided to revise the poly/head to fix the issue.After beginning the patient, it appeared difficult to dislocate her.We trialed a +4 head and she appeared extremely stable so he just changed out the head.No fault of stryker products at all, purely an accident from the patient falling off a ladder.".
Additional Manufacturer Narrative
An event regarding dislocation involving a ceramic head was reported.The event was not confirmed.Method & results: -product evaluation and results: not performed as the device was not returned.-medical records received and evaluation: not performed as no medical records were returned for review.-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 were no other events for the lot provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device return, 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 as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: DELTA V-40 CERAMIC HEAD 32/0
• 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: 7861730
• Report Number: 0002249697-2018-02809
• Device Sequence Number: 11257782
• Product Code: JDI
• UDI-Device Identifier: 04546540608505
• UDI-Public: 04546540608505
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2018

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: 08/31/2022
• Device Catalogue Number: 6570-0-132
• Device Lot Number: 60756803
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 11/15/2018
• 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: 79 YR