MAUDE Adverse Event Report: ZIMMER BIOMET, INC. POLY LINER PLUS 3 MM OFFSET 36 MM DIAMETER; SHOULDER, PROSTHESIS

Model Number	00-4349-036-03
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: comp rvrs shldr glnsp std 36mm cat: 115310 lot: 679140.Comp rvrs 25mm bsplt ha+adptr cat: 010000589 lot: 215130.Comp rvs cntrl 6.5x25mm st/rst cat: 115395 lot: 196720.Comp lk scr 3.5hex 4.75x30 st cat: 180553 lot: 217950.Comp lk scr 3.5hex 4.75x35 st cat: 180554 lot: 201230.Comp lk scr 3.5hex 4.75x15 st cat: 180550 lot: 202840.Comp lk scr 3.5hex 4.75x15 st cat: 180550 lot: 324280.Humeral stem 8 mm stem diameter 130 mm stem length cat: 00434900813 lot: 64188054.Report source: foreign: (b)(6).It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.
Event or Problem Description
It was reported that approximately 6 weeks post implantation, the patient was revised.The patient was noted to have an arm that was becoming ischemic.The surgeon highlighted that he felt the cause of dislocation was due to poor tuberosity healing and poor deltoid tensioning due to patient's anatomy.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Device history record 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.

• Brand Name: POLY LINER PLUS 3 MM OFFSET 36 MM DIAMETER
• Common Device Name: SHOULDER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12347739
• Report Number: 0001822565-2021-02338
• Device Sequence Number: 1244760
• Product Code: HSD
• UDI-Device Identifier: 00889024269064
• UDI-Public: (01)00889024269064
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K052906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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
• Operator of Device: Health Professional
• Device Model Number: 00-4349-036-03
• Device Catalogue Number: 00434903603
• Device Lot Number: 63953103
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention