MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL STEM NON-POROUS 13 MM STEM DIAMETER 130 MM STEM LENGTH; PROSTHESIS, EXTREMITIES

Catalog Number 00435001313

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Joint Dislocation (2374)

Event Date 03/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02238, 0001822565-2020-02246.Concomitant medical products: poly liner, part#: 00434906506, lot#: 64287460.Unk glenoid head.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product 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.

Event Description

It was reported patient underwent a shoulder revision approximately four (4) months ago due to the poly liner disengaging from the stem.The surgeon had only replaced the poly liner and kept the originally implanted stem.Approximately one (1) month post-revision, patient underwent a second revision due to the poly and stem disengaging and joint dislocation.Both the stem and poly liner were removed and replaced.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Insufficient information provided.Unable to perform a compatibility check.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: initial op notes dated 8 jan 2020 were reviewed and no deviations were noted.Revision op notes dated 10 feb 2020 were reviewed and identified open reduction and revision of right rtsa humeral component, poly spacer.Presented with increased pain, x-ray showed a dislocated shoulder.Closed reduction attempted but unsuccessful.Upon opening, the humeral poly component was noted to be displaced anterior and off the humeral stem.X-rays were not sent for mmi review as they do not enhance the investigation.Revision op notes dated 26 mar 2020 were reviewed and identified dislocation - revision of humeral component.Patient was opening a bag of carrots and felt something give in his shoulder, xrays showed a repeat dislocation.The poly spacer was again shown to be dissociated from the humeral component.Stem and poly exchanged without complication.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot 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 event information available at the time of this report.

• Brand Name: HUMERAL STEM NON-POROUS 13 MM STEM DIAMETER 130 MM STEM LENGTH
• Type of Device: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10186922
• MDR Text Key: 197089053
• Report Number: 0001822565-2020-02239
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00889024269323
• UDI-Public: (01)00889024269323
• Combination Product (y/n): N
• PMA/PMN Number: K130661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00435001313
• Device Lot Number: 63754535
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention