MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM STD LFIT V40 HEAD; HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number	6260-9-132
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.Additional information has been requested and if received will be provided in a supplemental report.Not returned.
Event or Problem Description
Head was opened into sterile field, surgeon recognized that it was discolored ( dark brown in the top section only instead of a silver color), it was not implanted the v40 lfit head.Theatre staff reported this faulty item to myself, stryker cnc, i took photos, it was decontaminated by washing in a turbo washer and then sterilizing to 135 degrees.
Additional Manufacturer Narrative
An event regarding appearance involving a metal head was reported.The event was confirmed following visual inspection of the photographs supplied.Conclusion: a capa investigation was conducted and concluded the following: the packaging foam is the source of the triazole-like species.The results of the cleaning trials indicates that the cleaning steps, and the position of the passivation step relevant to the ion bombardment process, play a key role in preventing discoloration developing on the lfit femoral heads.The reason for this may be that the ion bombardment process improves the wettability property of the parts and the passivation step, depending on whether it is completed pre or post ion bombardment, may affect the development of discoloration on the lfit femoral head.
Event or Problem Description
Head was opened into sterile field, surgeon recognized that it was discolored ( dark brown in the top section only instead of a silver color), it was not implanted the v40 lfit head.Theatre staff reported this faulty item to myself, stryker cnc, i took photos, it was decontaminated by washing in a turbo washer and then sterilizing to 135 degrees.

• Brand Name: 32MM STD LFIT V40 HEAD
• Common Device Name: HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7635587
• Report Number: 0002249697-2018-01954
• Device Sequence Number: 13485469
• Product Code: JDI
• UDI-Device Identifier: 07613327013047
• UDI-Public: 07613327013047
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K173499
• 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): 09/19/2018

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: 08/30/2022
• Device Catalogue Number: 6260-9-132
• Device Lot Number: 56607904
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 09/19/2018
• 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