MAUDE Adverse Event Report: ACUMED LLC ARH SLIDE-LOC¿ NECK +5MM; PROSTHESIS, ELBOW, NECK

Model Number 5001-0305N-S

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this event: mdr 3025141-2016-00139 stem, mdr 3025141-2016-00141 head.

Event Description

Arh slide-loc products were implanted on (b)(6) 2016.Post operatively, the head/neck assembly disassociated from the stem, potentially due to a fall experienced by the patient.The parts were explanted on (b)(6) 2016.

Manufacturer Narrative

The returned head, neck and stem parts were examined.The parts were received with the head and neck assembled.The laser lines on the head and the neck were aligned properly.The locking interface region on the neck was damaged.Damage to the interface was most likely caused by the stem clamp not being fulled seated on the stem prior to rotation.Lack of interference marks on the stem indicate that the head/neck assembly was not rotated to 45 degrees (the locked position).Additional mdrs associated with this event: mdr 3025141-2016-00139 stem follow up 1, mdr 3025141-2016-00141 head follow up 1.

• Brand Name: ARH SLIDE-LOC¿ NECK +5MM
• Type of Device: PROSTHESIS, ELBOW, 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 ; 5036279957
• MDR Report Key: 5758708
• MDR Text Key: 48442989
• Report Number: 3025141-2016-00140
• 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,Followup
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 06/30/2021
• Device Model Number: 5001-0305N-S
• Device Catalogue Number: 5001-0305N-S
• Device Lot Number: 327821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 159