MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL STEM 14 MM STEM DIAMETER 130 MM STEM LENGTH; PROSTHESIS SHOULDER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Debris, Bone Shedding (1803); Failure of Implant (1924); Pain (1994); Joint Dislocation (2374)

Event Date 01/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).(udi): n/a.Medical product: catalog #: 00434901413, humeral stem 14 mm stem, lot #: 62908449.Catalog #: 00434906606, retentive poly liner plus, lot #: 03594043pe.Catalog #: 00434901500, base plate 15 mm post length uncemented, lot #: 62926996.Catalog #: 00434904011, glenosphere 40 mm diameter, lot #: 62859929.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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: 0001822565-2020-00563.Requested but not returned by hospital.

Event Description

It was reported that the patient underwent an initial revision of the left shoulder due to instability.Subsequently patient experienced subluxation and underwent closed reduction, pain, instability and underwent a second revision due to liner disassociation.No additional information is available form the event.

Event Description

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

Manufacturer Narrative

(b)(4).Visual examination of the provided pictures identified that all devices are explanted.Stem has bone tissue on the porous shaft.Poly liner is damaged on the bottom and has blood tissue.Glenosphere was explanted.On the x-rays is showed previous bone loss, ho, and instability.It also noted good position, no impingement, evidence stress shielding noted on the proximal anterolateral.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: 0001822565-2020-02332.

• Brand Name: HUMERAL STEM 14 MM STEM DIAMETER 130 MM STEM LENGTH
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9694253
• MDR Text Key: 183013692
• Report Number: 0001822565-2020-00562
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• 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: 00434901413
• Device Lot Number: 62908449
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2020
• 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: 80