MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 28MM STD V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number	6260-5-128
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
When surgeon was performing the hip-joint replacement surgery, he found that after he connected the accolade hfx handle to 28mm std v40 taper vit head, they were loosening and could not be fastened.The surgery process has been affected, after coordinated, the surgeon replaced with a taper vit head which has the same cone angel, and finished the surgery.The surgeon replaced with a taper vit head with a larger diameter and the same con angel, the substitute product item: 6260-5-228,28mm+4mm, afterwards the surgery was finished.
Additional Manufacturer Narrative
An event regarding a siz/fit issue involving a metal head was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection: visual inspection of the return part was carried out.The device was visually unremarkable.Dimensional inspection: dimensional inspection was carried out on the returned head.All dimensions were found to be within specification.-medical records received and evaluation: no information was received for review with a clinical consultant.No adverse impact to patient was noted.-device history review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review indicated there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined, the metal head was found to be dimensionally within specifications.If additional information becomes available, this investigation will be reopened.
Event or Problem Description
When surgeon was performing the hip-joint replacement surgery, he found that after he connected the accolade hfx handle to 28mm std v40 taper vit head, they were loosening and could not be fastened.The surgery process has been affected, after coordinated, the surgeon replaced with a taper vit head which has the same cone angel, and finished the surgery.The surgeon replaced with a taper vit head with a larger diameter and the same con angel, the substitute product item: 6260-5-228,28mm+4mm, afterwards the surgery was finished.

• Brand Name: 28MM STD V40 TAPER VIT HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6272897
• Report Number: 0002249697-2017-00316
• Device Sequence Number: 19001756
• Product Code: LWJ
• UDI-Device Identifier: 07613327012866
• UDI-Public: (01)07613327012866(11)150705(17)200731(10)52347501
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K993601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 6260-5-128
• Device Lot Number: 52347501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2017
• Supplement Report FDA Received Date: 03/28/2017
• 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