MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM -4 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6260-9-032
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the product history records indicate the products were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Surgeon reported that when he placed definitive head on to exeter stem, the head fit loosely.After impacting with head impactor and mallet, the head was able to be removed by hand.Another head was opened and used.
Event or Problem Description
Surgeon reported that when he placed definitive head on to exeter stem, the head fit loosely.After impacting with head impactor and mallet, the head was able to be removed by hand.Another head was opened and used.
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: a visual inspection of the returned part noted nothing remarkable dimensional inspection: a dimensional inspection was carried out on the returned part using inspection guidesheet , (b)(4).The returned device was noted to be dimensionally 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 returned device was found to be dimensionally in specification and functionally correct.If additional information becomes available, this investigation will be reopened.

• Brand Name: 32MM -4 LFIT V40 HEAD
• 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: 6991535
• Report Number: 0002249697-2017-03167
• Device Sequence Number: 1227906
• Product Code: LPH
• UDI-Device Identifier: 07613327013009
• UDI-Public: 07613327013009
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K121308
• 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): 01/10/2018

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: 06/15/2022
• Device Catalogue Number: 6260-9-032
• Device Lot Number: 59890304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Initial Date Received by Manufacturer: 10/04/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 10/31/2017
• Supplement Report FDA Received Date: 01/10/2018
• 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: Other