MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +8 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-9-332
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the product 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.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
During total hip replacement, hospital staff (scrub nurse) opened sterile implant( lfit head) and noticed it was discoloured.It was darker on top and the sides remained normal silver colouring.The surgeon did not want to use it and staff opened another lfit head of the same size which was not discoloured.This was then used to complete the surgery.
Additional Manufacturer Narrative
An event regarding appearance involving a metal head was reported.The event was confirmed.Method & results: device evaluation and results: ma examination of the returned device with engineer indicated that the product is within scope of a capa related to the discoloration of these products.Visual inspection: visual inspection was performed as part of the material evaluation and indicated the following comments: examination of the returned device with engineer indicated that the product is within scope of a capa related to the discoloration of these products.Functional and dimensional insepction: not performed as these aspects are not in question.Clinician review: no medical records were received for review with a clinical consultant.Device 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.Conclusion: the subject device has been identified to be within scope of a capa.The heads were not implanted.Further, a sample of femoral heads was inspected with no failures.The capa found that the failure mode of localized discolouration on the lfit femoral head is equal to, or lower than, 1%.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
During total hip replacement, hospital staff (scrub nurse) opened sterile implant( lfit head) and noticed it was discoloured.It was darker on top and the sides remained normal silver colouring.The surgeon did not want to use it and staff opened another lfit head of the same size which was not discoloured.This was then used to complete the surgery.

• Brand Name: 32MM +8 LFIT V40 HEAD
• 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: 9328744
• Report Number: 0002249697-2019-03769
• Device Sequence Number: 13915753
• Product Code: JDI
• UDI-Device Identifier: 07613327013122
• UDI-Public: 07613327013122
• 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): 01/17/2020

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: 08/31/2020
• Device Model Number: 6260-9-332
• Device Catalogue Number: 6260-9-332
• Device Lot Number: 52440305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 01/17/2020
• 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