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

Model Number	114-2010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: CEMENT RESTRICTOR
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• MDR Report Key: 10963289
• Report Number: 1722511-2020-00036
• Device Sequence Number: 13693152
• Product Code: KWY
• UDI-Device Identifier: 00822409012954
• UDI-Public: (01)00822409012954(17)230719(10)A198332
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K962448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2020

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: 07/19/2023
• Device Model Number: 114-2010
• Device Lot Number: A198332
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1