MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ARCOM XL 44-36 STD +3 HMRL BRG; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 02/16/2015

Event Type  Injury  

Event Description

It was reported that patient underwent a right total shoulder arthroplasty on (b)(6) 2014.Subsequently, patient was revised on (b)(6) 2015 due to dislocation.The humeral bearing, taper adapter, humeral tray and glenoid were removed and replaced.Patient was further revised on (b)(6) 2015 due to dislocation.The humeral bearing, humeral tray and stem were removed and replaced.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, states, ¿dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions.¿ this report is number 3 of 3 mdrs filed for the same event (reference 1825034-2015-00729 / 00730 & 01818).

Event Description

It was reported a patient underwent shoulder revision approximately three weeks post-implantation due to anterior dislocation.During the procedure, it was found the gleonosphere was intact and not loose; the humeral component was anteverted.All humeral components were revised.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: xl-115364 arcom xl 44-36 std +3 hmrl brg 450630.115310 comp rvrs shldr glnsp std 36mm 910890.118001 versa-dial/comp ti std taper 177620.115396 comp rvs cntrl 6.5x30mm st/rst 990670.Xl-115364 arcom xl 44-36 std +3 hmrl brg 596270.113637 comp primary stem 17mm mini 215100.115375 comp rvs tray +5mm co 44mm 862450.115370 comp rvs tray co 44mm 327760.115330 comp rvrs shdr glen bsplt +ha 929360.180551 comp lk scr 3.5hex 4.75x20 st 825120.180551 comp lk scr 3.5hex 4.75x20 st 028160.180559 comp nlk scr 3.5hex 4.75x25 st 114120.180558 comp nlk scr 3.5hex 4.75x20 st 652610.118001 versa-dial/comp ti std taper 667100.115313 comp rvsr shldr glnsp +3 36mm 977070.Reported event was confirmed by review of the provided op notes.From the first revision operative records: patient was grossly unstable.The glenoid side had spun around from being inferiorly displaced to being superiorly displaced.From the second revision operative records: the glenosphere was intact and not loose.It appeared that the humeral component was anteverted and the whole humeral component was removed from the shaft.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.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, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 4731774
• MDR Text Key: 17583226
• Report Number: 0001825034-2015-01818
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2019
• Device Model Number: N/A
• Device Catalogue Number: XL-115364
• Device Lot Number: 596270
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR