MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM REVERSE GLENOSPHERE 36 MM DIAMETER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Joint Dislocation (2374)

Event Date 04/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown humeral stem, unknown glenoid.Reported event was unable to be confirmed.Dhr review was unable to be performed as the item and lot number of the device involved in the event is unknown.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 05852, 0001822565 - 2018 - 05853.

Event Description

It was reported that the patient underwent a shoulder arthroplasty revision surgery due to infection.Patient is additionally experiencing ongoing pain and limited mobility.No additional information is made available.

Manufacturer Narrative

The follow up report is submitted to relay additional information received 00434906506 retentive poly liner plus (+) 6 mm offset 36 mm diameter 65 degree neck angle 63295422 00434902502 base plate 25 mm post length +2 mm lateral offset uncemented 63799968 0104223033 anatomical shoulderâ?¢ reverse, screw system, 4.5-33 2857358 0104223042 anatomical shoulderâ?¢ reverse, screw system, 4.5-42 2865695 00434901013 humeral stem 10 mm stem diameter 130 mm stem length 63662474 00434903909 humeral stem spacer size 9 63896767 the complaint is under investigation.Once the investigation is completed a follow up report will be submitted.

Event Description

It was reported that the patient underwent a previous right revision shoulder arthroplasty for dislocation.Subsequently, the patient was revised due to dislocation and instability approximately nineteen (19) days post-op.Surgeon mentioned there was possible infection and removed all the products and placed an antibiotic cement hemi-arthroplasty, however, in follow-up notes, no infection was noted to be found.No additional information is available.

Event Description

It was reported that the patient underwent a previous right revision shoulder arthroplasty for dislocation.Subsequently, the patient was revised due to dislocation and instability approximately nineteen (19) days post-op.Surgeon mentioned there was possible infection and removed all the products and placed an antibiotic cement hemi-arthroplasty.No additional information is available.

Manufacturer Narrative

The following report is being submitted to relay additional information received: udi: (b)(4).The complaint was confirmed based on the medical records provided stating turbid fluid was seen and x-rays review stating dislocation.The device history records were reviewed and no deviations/ anomalies identified.A definitive root cause cannot be determined.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.[mw5079657.Pdf].

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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 is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h2, h3, h6, h10 medical records were provided and reviewed by a health care professional.Review of the available records identified the following: two units prbcs transfused.Received information will not change previous root cause.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: TM REVERSE GLENOSPHERE 36 MM DIAMETER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7997371
• MDR Text Key: 124789419
• Report Number: 0001822565-2018-05851
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K121543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00434903611
• Device Lot Number: 63606546
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2020
• 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: 104