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

Model Number	700-0015
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: TOTAL HIP PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• MDR Report Key: 9296368
• Report Number: 1722511-2019-00027
• Device Sequence Number: 390220
• Product Code: KWL
• UDI-Device Identifier: 00822409000074
• UDI-Public: (01)00822409000074(17)230530(10)A195291
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K141001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR