MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOM XL 44-36 STD +3 HMRL BRG; PROSTHESIS, EXTREMITY

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Tissue Breakdown (2681); No Code Available (3191)

Event Date 06/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the patient was revised due to a loose joint/dislocation.Loss of rotator cuff and soft tissue were identified as contributing conditions.No further information has been made available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: comp rvsr shldr glnsp +3 36mm, cat: 115313, lot: 434000; comp primary stem 6 x 194 rev, cat: 113666, lot: 503390; comp.Rev shldr 9 in steinmann, cat: 405800, lot: 930600; comp rvs tray +10mm co 44mm, cat: 115378, lot: 621420; comp lk scr 3.5hex 4.75x20 st, cat: 180551, lot: 196430; comp lk scr 3.5hex 4.75x20 st, cat: 180551, lot: 488590; versa-dial taper adaptor 25mm, cat: 110031378, lot: 716090; compr vrs glen pps min tpr adr, cat: 110027734, lot: 716060; comp lk scr 3.5hex 4.75x30 st, cat: 180553, lot: 333540; comp lk scr 3.5hex 4.75x35 st, cat: 180554, lot: 095420; comp rvs cntrl 6.5x35mm st/rst, cat: 115397, lot: 927940.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ARCOM XL 44-36 STD +3 HMRL BRG
• Type of Device: PROSTHESIS, EXTREMITY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6882998
• MDR Text Key: 87171584
• Report Number: 0001825034-2017-07201
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/05/2022
• Device Model Number: N/A
• Device Catalogue Number: XL-115364
• Device Lot Number: 636530
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2017
• Initial Date FDA Received: 09/21/2017
• Supplement Dates Manufacturer Received: 01/30/2018
• Supplement Dates FDA Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR