MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS SHLDR GLNSP +6 36MM; PROSTHESIS SHOULDER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Ambulation Difficulties (2544)

Event Date 01/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: catalog #: 110031399, mini humeral tray standard thickness, lot # 64396704.Catalog #: 110031418, bearing standard 36 mm diameter, lot # 64343765.Catalog #: 113625, comp primary stem 5mm mini, lot # 434380.Catalog #: 115316, comp rvrs shldr glnsp +6 36mm, lot # 829820.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent an initial surgery approximately 1.5 years ago.Subsequently, about 1 month later, the patient had a revision due to dislocation.The patient is wheelchair bound, chronic dislocator patient, and has anatomy issues.The doctor didn¿t think he could do a reverse, however when he went in, he got the baseplate hung, patient was doing well, then dislocated.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information 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.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2021-00954 and 0001825034-2021-02495.

Manufacturer Narrative

(b)(4).Corrected: d1, d4 (item, lot, exp date).D10 - medical product: catalog#: 010000589, comp rvrs 25mm bsplt ha+adptr r, lot#: 966260.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: COMP RVRS SHLDR GLNSP +6 36MM
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11602941
• MDR Text Key: 243539833
• Report Number: 0001825034-2021-00954
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304532455
• UDI-Public: (01)00880304532455(17)290925(10)966260
• Combination Product (y/n): N
• PMA/PMN Number: K080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 115316
• Device Lot Number: 829820
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/10/2021
• Initial Date FDA Received: 04/01/2021
• Supplement Dates Manufacturer Received: 07/06/2021; 08/20/2021
• Supplement Dates FDA Received: 07/22/2021; 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention