MAUDE Adverse Event Report: ACUMED LLC; PROSTHESIS, ELBOW, HEMI-, RADIAL, NECK

Device Problem Insufficient Information (3190)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2017-00166: head, 3025141-2017-00168: stem.

Event Description

Arh slide-loc radial head replacement surgery took place on (b)(6) 2017.A second surgery occurred on (b)(6) 2017 where the doctor planned to release soft tissue and potentially change or remove the radial head replacement implants.The implants were intact and fit correctly so they were not removed/replaced.

• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, NECK
• Manufacturer (Section D): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124 9432
• Manufacturer (Section G): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124 9432
• Manufacturer Contact: micki lehman ; 5885 nw cornelius pass road; hillsboro, OR 97124-9432 ; 8886279957
• MDR Report Key: 6718525
• MDR Text Key: 80201861
• Report Number: 3025141-2017-00167
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 51 YR
• Patient Weight: 68