MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TROCHANTERIC GRIP PLATE WITH 2; PLATE, FIXATION, BONE

Catalog Number	6704-3-081
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348); Joint Dislocation (2374)
Date of Event	04/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a dall miles plate was reported.The event was confirmed.Method & results: device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical records and/or x-rays by a clinical consultant indicated: the trochanteric non-union is still present with failure of bony healing as evident by the loose pieces of bone on x-ray and the fractured dm-cables and loose dm-plate.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 investigation concluded that the event was caused by non-union of a greater trochanteric fracture, present already before implantation of the predicate devices after a periprosthetic fracture due to a fall of the patient in 2015, despite adequate treatment, has contributed to an overload condition on the implanted constrained liner forcing a complete pull-out of the constrained liner from the cup shell requiring a third revision in (b)(6) 2018.The trochanteric non-union is still present with failure of bony healing as evident by the loose pieces of bone on x-ray and the fractured dm-cables and loose dm-plate.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened; not returned.
Event or Problem Description
As reported: "chronic dislocations, constrained liner damage during dislocation.[dall miles] plate removed"; left hip.Update 14 june, 2018: the medical review has confirmed that the constrained liner has disassociated from an unknown trident shell.It has also confirmed loosening of the dall miles plate.The conclusion of the assessment is as follows: "non-union of a greater trochanteric fracture, present already before implantation of the predicate devices after a periprosthetic fracture due to a fall of the patient in 2015, despite adequate treatment, has contributed to an overload condition on the implanted constrained liner forcing a complete pull-out of the constrained liner from the cup shell requiring a third revision in (b)(6) 2018".Update 18 june 18: a review by a clinical consultant has confirmed a fractured dall miles cable.

• Brand Name: TROCHANTERIC GRIP PLATE WITH 2
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7681399
• Report Number: 0002249697-2018-02146
• Device Sequence Number: 1398969
• Product Code: HRS
• UDI-Device Identifier: 04546540568106
• UDI-Public: 04546540568106
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K070170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 6704-3-081
• Device Lot Number: G6172347
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 07/12/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Weight: 51