MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE PRIMARY STEM 6MM MINI; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Failure To Adhere Or Bond (1031); Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Failure of Implant (1924); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Joint Dislocation (2374); Patient Problem/Medical Problem (2688)

Event Date 02/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown, unknown comprehensive humeral tray, unknown, unknown, unknown comprehensive humeral bearing, unknown, unknown, unknown comprehensive glenosphere, unknown, unknown, unknown comprehensive taper, unknown, unknown, unknown comprehensive glenoid baseplate, 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: 0001825034 - 2018 - 01123, 0001825034 - 2018 - 01124, 0001825034 - 2018 - 01125, 0001825034 - 2018 - 01126, 0001825034 - 2018 - 01127.

Event Description

It was reported by the patient¿s legal counsel that the patient underwent left shoulder arthroplasty.Subsequently, the patient underwent a revision procedure on an unknown date due to pain and loss of function.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed as part number/ lot number of device involved in the incident is unknown and due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.Product location unknown.

Manufacturer Narrative

(b)(4).Review of the complaint history was not performed as part number/ lot number of device involved in the incident is unknown.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of operative notes.Per the initial op notes, the initial surgery was due to 4-part fracture dislocation with malunion and ectopic bone and stiffness.There were no noted complications or delays in the procedure.Per the revision op notes, the patient underwent open reduction due to dislocation.Without much difficulty, the humeral prosthesis was explanted and found to have no evidence of bone ingrowth.Baseplate was felt to be stable.During the implantation of the new humeral stem, a thin hairline crack appeared in the anterior humeral cortex.This was managed with a competitor cable.There were no other noted complications or delays in the procedure.Dhr was reviewed and no discrepancies were found.Root cause was unable to 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.

Event Description

No further information provided at the time of this reporting.

Manufacturer Narrative

(b)(4).Reported event was confirmed via review of operative notes received from the customer.Dhr was reviewed and no discrepancies were found.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

This follow-up report is being submitted to relay additional information.The following sections were updated: catalog #113626, comprehensive primary stem 6mm mini, lot #080000; catalog #xl-115363, arcom xl 44-36 standard humeral bearing, lot #741520; catalog #115370, comprehensive revers tray co 44mm, lot #697190; catalog #115310, comprehensive reverse shoulder glenosphere std 36mm, lot #741520; catalog #010000589, comprehensive reverse 25mm baseplate ha+adapter, lot #790140; catalog #115395, comprehensive reverse central screw 6.5x25mm st/rst, lot #080000; catalog #180553, comprehensive locking screw 3.5hex 4.75x30 st, lot #080000; catalog #180553, comprehensive locking screw 3.5hex 4.75x30 st, lot #080000.After receipt of additional information another investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

It was reported that a patient underwent a total reverse shoulder arthroplasty.Subsequently, patient was revised due to chronically dislocated shoulder.Patient was experiencing pain before this revision.During the procedure, the humeral stem prosthesis was removed without much difficulty and showed no evidence of bone ingrowth.Heterotopic bone on the humerus and scar tissue were additionally noted.New implants were put in place and the procedure was completed successfully.

Event Description

It was reported that the patient underwent an initial left reverse total shoulder arthroplasty.A revision was performed of the glenoid and humeral components.During the revision procedure, extensive scar tissue was noted which also encapsulated the axillary nerve.The humeral stem was noted to have no evidence of bony ingrowth.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause has not changed since the previous investigation, and remains undetermined.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: COMPREHENSIVE PRIMARY STEM 6MM MINI
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7279765
• MDR Text Key: 100413474
• Report Number: 0001825034-2018-01122
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: PK060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 113626
• Device Lot Number: 080000
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2019
• 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: 65 YR