MAUDE Adverse Event Report: ORTHO DEVELOPMENT ALPINE; TOTAL HIP PROSTHESIS

Model Number 700-0015

Device Problem Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Type  Injury  

Event Description

The surgeon revised a patient due to lucency on x-ray and thigh pain and replaced the hip stem with a modular, fluted stem.

Manufacturer Narrative

The returned part was examined.No x-rays were provided.There was a significant amount of bony tissue adhered to the porous coating of the stem.There were significant score marks on the proximal portion of the stem consistent with osteotome utilization for stem removal.The bony tissue and score marks are suggestive of bony fixation.There were no other indicators or observations that would explain how this device contributed to the reported incident.

• Brand Name: ALPINE
• Type of Device: TOTAL HIP PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• MDR Report Key: 9296368
• MDR Text Key: 167366028
• Report Number: 1722511-2019-00027
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00822409000074
• UDI-Public: (01)00822409000074(17)230530(10)A195291
• Combination Product (y/n): N
• PMA/PMN Number: K141001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2023
• Device Model Number: 700-0015
• Device Lot Number: A195291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 10/11/2019
• Supplement Dates FDA Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR