MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM STD LFIT V40 HEAD; HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES

Catalog Number	6260-9-132
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no relevant 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
The package with implant opened; paper got separated when opening and became unsterile.
Additional Manufacturer Narrative
An event regarding a packaging issue involving a metal head was reported.The event was confirmed.Method & results: product evaluation and results: visual inspection: as per the review completed by the senior manufacturing engineer and senior quality engineer of the packaging area; the inner blister was intact and correctly sealed.The outer blister seal area was complete and indicated the presence of a full and complete seal when the blister was unopened.An inspection of the returned part showed that a patient label had been adhered to the outer tyvek in the area where the delamination occurred, dimensional inspection: the reported clinical event does not relate to a dimensional issue.Functional inspection: not performed as the functional aspects are not in question.Material analysis: not performed as this event does not relate to material integrity medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: the senior manufacturing engineer and senior quality engineer of the packaging area reviewed the event and the device returned and concluded that the patient label applied to the outer blister tyvek and the attempted removal of this label is the probable cause of the delamination in the tyvek when opening the blister.However, the exact cause of the event could not be determined because further information such as 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 insufficient information was received by stryker orthopaedics.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The package with implant opened; paper got separated when opening and became unsterile.

• Brand Name: 32MM STD LFIT V40 HEAD
• Common Device Name: HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7153949
• Report Number: 0002249697-2017-03766
• Device Sequence Number: 19180902
• Product Code: LPH
• UDI-Device Identifier: 07613327013047
• UDI-Public: 07613327013047
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2018

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: 09/19/2022
• Device Catalogue Number: 6260-9-132
• Device Lot Number: 60980107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 02/13/2018
• 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