MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ANATO STEM SZ 4 LEFT NEUT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 4845-7-214

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)

Patient Problems Bone Fracture(s) (1870); Injury (2348); Joint Dislocation (2374)

Event Date 10/13/2016

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.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 events for the lot referenced.

Event Description

Patient underwent total hip revision for periprosthetic femur fracture and dislocation.Only stem and head exchanged.

Event Description

Patient underwent total hip revision for periprosthetic femur fracture and dislocation.Only stem and head exchanged.

Manufacturer Narrative

Reported event: an event regarding periprosthetic fracture and an incorrect selection of an undersized stem resulting in subsidence involving an anato stem was reported.The incorrect selection of an undersized stem resulting in subsidence was confirmed through a medical review of the provided medical records.Periprostheic fracture and dislocation were not confirmed.Method & results: device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: x-rays taken one month after her index surgery demonstrated an undersized pressfit stem that appears to have subsided.Device history review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review indicated there have been no other similar events for the reported lot.Conclusions: the investigation concluded that x-rays taken one month after her index surgery demonstrated an undersized pressfit stem that appears to have subsided.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: ANATO STEM SZ 4 LEFT NEUT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6417644
• MDR Text Key: 70351693
• Report Number: 0002249697-2017-00950
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 4845-7-214
• Device Lot Number: 50142403
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2017
• Initial Date FDA Received: 03/20/2017
• Supplement Dates Manufacturer Received: 04/16/2019
• Supplement Dates FDA Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 113