MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RETENTIVE POLY LINER; PROTHESIS, SHOULDER

Model Number N/A

Device Problems Disassembly (1168); Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problem Joint Dislocation (2374)

Event Date 12/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) concomitant medical products: unknown, unknown head, unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-01218.

Event Description

It was reported that a patient underwent an initial shoulder procedure on unknown date.Subsequently, the patient was revised due to dislocation on unknown date.Attempts have been made and additional information on the reported event is unavailable.

Event Description

It has been reported that patient was revised due to dislocation for the second time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event 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.

Manufacturer Narrative

(b)(4).D11 - medical product: catalog #: 00434903611, glenosphere 36 mm diameter, lot # 63736820, catalog #: 00434901500, base plate 15 mm post length uncemented, lot # 63755874.Reported event was considered confirmed from the medical records and x-rays which found the glenosphere to be dislodged.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02989.

Event Description

It was reported that a patient underwent an initial shoulder procedure approximately 3 years ago.Subsequently, the patient was revised due to dislocation about a month later which is been covered under another complaint.However the patient had a second dislocation of the liner and was revised again about a month after the first.During the procedure it was noted that the glenosphere had disassociated from the baseplate.

Manufacturer Narrative

(b)(4).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

No further event information available at the time of this report.

• Brand Name: RETENTIVE POLY LINER
• Type of Device: PROTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7302293
• MDR Text Key: 101129253
• Report Number: 0001822565-2018-01217
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: PK121543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00434906506
• Device Lot Number: 63295422
• Other Device ID Number: (01) 00889024269194
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2020
• 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 Weight: 100