MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE; BONE SCREW

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Foreign Body Reaction (1868); Pain (1994)

Event Date 08/25/2017

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(4).The 115381 comp rvs cntrl scr 6.5x25 mm st 319780; 180501 comp locking screw 4.75x20 mm 436140; 180502 comp locking screw 4.75x25 mm 788750; xl-115363 arcom xl 44-36 std hmrl brng 520600.Reported event was confirmed by review of x-rays and provided op notes.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required x-rays right shoulder ap, axillary and scapular views comprehensive right reverse shoulder arthroplasty with disassociated glenosphere which has migrated anteriorly and cranially, and is tilted superiorly.Scapular notching is present along with heterotopic ossification versus fracture deformity of the inferior glenoid rim.Op notes removal of aseptically loose reversed right total shoulder arthroplasty.The scarred anterior shoulder capsule was incised and extensive metallosis was encountered.Radiographs showed severe osteopenia.The poly cup and metal tray were removed from the morse taper on the stem, exposing glenoid.The glenosphere was grossly loose and had separated from the baseplate, which was grossly loose.No screws had any fixation and the baseplate and screws were removed.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.

Event Description

It was reported a patient underwent shoulder revision approximately eight years post-implantation due to pain, dysfunction, aseptic loosening, elevated metal ion levels, and adverse local tissue reaction.During the revision, the glenosphere and baseplate were found to be loose.Extensive wear on trunnion was noted, which is suspected to be the source of the metallosis and metal ion elevation.All components were revised.

• Brand Name: COMPREHENSIVE
• Type of Device: BONE SCREW
• 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: 7154088
• MDR Text Key: 96029064
• Report Number: 0001825034-2017-11506
• 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
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 180501
• Device Lot Number: 436140
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2009
• 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: 63 YR