MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER TRABECULAR METAL REVERSE POLYETHYLENE OFFSET LINER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 08/06/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products - zimmer trabecular metal reverse shoulder inverse/reverse screw system catalog #: 01.04223.033 lot #: 2656649, zimmer trabecular metal reverse shoulder inverse/reverse screw system catalog #: 01.04223.048 lot #: 2553194, zimmer trabecular metal reverse glenosphere catalog #: 00434904011 lot #: 61955405, zimmer trabecular metal reverse humeral stem catalog #: 00434901013 lot #: 62168004, zimmer trabecular metal reverse shoulder base plate catalog #: 00434903811 lot #: 62172470.Complaint sample was evaluated and the reported event was confirmed.Baseplate, glenosphere and liner received for evaluation.Dimensions taken on baseplate and glenosphere are within specification.The base plate exhibits severe gouges and damage on the taper.Poly liner exhibits severe damage and an indentation along the back edge of the anti-rotational slot.The glenosphere did not sit flat on the baseplate when assembled.The witness marks around the slot that accepts the anti-rotation boss of the stem could indicate that the liner was not suitably aligned with the anti-rotation boss of the stem.It is stated in op-notes from primary surgery (b)(6) 2013 that "a new reverse retentive polyethylene liner with 40 mm inside diameter and 6.0 mm offset were impacted into the metaphyaoal portion of the trabecular metal humeral component.At this point, the modular humeral component was observed to be secure in its position with approximately 10 degrees of retroversion." device history records (dhrs) were reviewed for baseplate and glenosphere with no discrepancies found.Dhr for the liner could not be reviewed since the lot number is unknown.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined.Multiple mdr reports were filed for this event, please see associated reports: 1822565-2015-02327, 1822565-2017-01737.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 by the patient's legal counsel that the patient underwent left shoulder arthroplasty revision due to pain, disassociation of the glenosphere, component loosening and wear less than two years following elbow arthroplasty.It is further alleged that improper installation of the baseplate screws resulted in a gap between the baseplate and the glenoid and that such a gap resulted in the looseness, pain, wear, and disassociation of the glenosphere.Attempts have been made and additional information on the reported event is unavailable.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.

• Brand Name: ZIMMER TRABECULAR METAL REVERSE POLYETHYLENE OFFSET LINER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6636108
• MDR Text Key: 77407819
• Report Number: 0001822565-2017-03985
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00434904006
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2017
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 75