MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ANATO STEM SZ 5 RIGHT NEUT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	4845-7-115
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	03/14/2019
Type of Reportable Event	Serious Injury
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
Surgeon commented that the greater trochanter fractured through the insertion site of the proximal checkpoint during the joint reduction with stem implant and trial head during mako direct anterior approach tha.The surgeon also commented that he did not believe that the checkpoint caused the fracture.The fracture was repaired with a cerclage cable.Surgical delay: 16-30 minutes.
Event or Problem Description
Surgeon commented that the greater trochanter fractured through the insertion site of the proximal checkpoint during the joint reduction with stem implant and trial head during mako direct anterior approach tha.The surgeon also commented that he did not believe that the checkpoint caused the fracture.The fracture was repaired with a cerclage cable.Surgical delay: 16-30 minutes.
Additional Manufacturer Narrative
An event regarding intraop fracture involving an anato stem was reported.The event was confirmed following a review of provided medical records by clinical consultant.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: "provided post-op x-ray confirms fracture fixed with dall-miles cables.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components" 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 lot referenced.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.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 5 RIGHT NEUT
• 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: 8503625
• Report Number: 0002249697-2019-01577
• Device Sequence Number: 10818533
• Product Code: LPH
• UDI-Device Identifier: 07613252631170
• UDI-Public: 07613252631170
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 4845-7-115
• Device Lot Number: 54094803
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 05/13/2019
• 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: 52 YR
• Patient Weight: 56