MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 26MM STD LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6260-9-126
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar 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
It was reported that during a primary hip procedure, a femoral head from loaners slid on and off the stem with ease, both when placing by hand or using a pusher.Another implant was opened and used, and the surgeon was satisfied with the fixation provided.As reported by rep: "he was able to remove the head with ease by hand even after impacting it on the stem with a pusher and mallet.After a couple attempts we opened a new lfit v40 head and was able to successfully impact it on the stem." surgical delay of 5 minutes was confirmed by the rep.
Additional Manufacturer Narrative
Product available to stryker.An event regarding a size/fit issue involving a metal head was reported.The event was not confirmed.Visual inspection of the returned device has nothing remarkable to report.Dimensional inspection: the device is dimensionally within specification as per inspection completed.Functional inspection: not performed because the event is related to in-vivo performance and therefore functionality could not be duplicated.Material analysis: not performed as there is no indication the event is related to a material integrity issue as there is evidence from the visual inspection that there is no damage to the device.No medical records were received for review with a clinical consultant all devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.The exact cause of the event could not be determined because insufficient information was provided.Further information such as operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.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
It was reported that during a primary hip procedure, a femoral head from loaners slid on and off the stem with ease, both when placing by hand or using a pusher.Another implant was opened and used, and the surgeon was satisfied with the fixation provided.As reported by rep: "he was able to remove the head with ease by hand even after impacting it on the stem with a pusher and mallet.After a couple attempts we opened a new lfit v40 head and was able to successfully impact it on the stem." surgical delay of 5 minutes was confirmed by the rep.

• Brand Name: 26MM STD 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: 7303222
• Report Number: 0002249697-2018-00572
• Device Sequence Number: 2248698
• Product Code: LPH
• UDI-Device Identifier: 07613327013030
• UDI-Public: 07613327013030
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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): 03/28/2018

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: 12/31/2022
• Device Catalogue Number: 6260-9-126
• Device Lot Number: 62051205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 03/28/2018
• 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
• Patient Age: 82 YR