MAUDE Adverse Event Report: ORTHO DEVELOPMENT ENCOMPASS HIP STEM; CEMENT RESTRICTOR

Model Number 114-2010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Date of event: the date that the 10mm cement restrictor was implanted is unclear.The second surgery occurred in response to the index surgery that occurred on (b)(6) 2019.Implant date.The implant date of the 10mm cement restrictor is unclear.The second surgery occurred in response to the index surgery that occurred on (b)(6) 2019.

Event Description

Post operative images revealed a bone crack that is believed to have occurred on (b)(6)2019 during cementless bipolar hemiarthroplasty possibly when the stem was inserted.A subsequent surgery was performed and the surgeon applied cable to the fracture as well as bone cement in conjunction with a 10mm cement restrictor.Post operative images showed anterior twist so another surgery was performed and the stem was removed and replaced with a stem made by another company.The cement restrictor was left in the patient.The original femoral stem and the 10mm bone restrictor were manufactured by this company.The cable, cement, and second stem were manufactured by another company.This mdr report is the second of two being submitted for this incident and addresses the 10mm cement restrictor.

• Brand Name: ENCOMPASS HIP STEM
• Type of Device: CEMENT RESTRICTOR
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer (Section G): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer Contact: drew weaver ; 12187 s. business park drive; draper, UT 84020 ; 8015539991
• MDR Report Key: 10963289
• MDR Text Key: 220216016
• Report Number: 1722511-2020-00036
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00822409012954
• UDI-Public: (01)00822409012954(17)230719(10)A198332
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K962448
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2023
• Device Model Number: 114-2010
• Device Lot Number: A198332
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1