MAUDE Adverse Event Report: ZIMMER BIOMET, INC. POLY LINER PLUS 0 MM OFFSET 36 MM DIAMETER; EXTREMITIES, IMPLANT

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item# 115310; lot# 002530; comp rvrs shldr glnsp std 36mm.Item# 010000589; lot# 293070; comp rvrs 25mm bsplt ha+adptr.Item# 00434901213; lot# 64430724; humeral stem 12 mm stem diameter 130 mm stem length.Item# 00430004615; lot# 62628874; modular humeral head 15 mm head height 46 mm spherical.Head diameter.Item# 00434903700; lot# unk; dual taper insert.Item# pm0002765; lot# 818030; mcgregor lt pm mini rvs gld.Item# 180552; lot# 583350; comp lk scr 3.5hex 4.75x25 st.Item# 180553; lot# 035520; comp lk scr 3.5hex 4.75x30 st.Item# 115396; lot# 207160; comp rvs cntrl 6.5x30mm st/rst.Item# 180560; lot# 042490; comp nlk scr 3.5hex 4.75x30 st.Foreign report source: (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 mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial shoulder procedure.Subsequently, the patient was revised due to dislocation.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays.There is a displaced hardware component, likely the glenosphere which is separated from the base plate and positioned posterior and slightly lateral to the normal positioning at the level of the glenoid, located along the posterior proximal diaphysis of the humerus, seen on the axillary view of the shoulder.The displaced glenosphere component is superimposed upon the humeral head component, difficult to assess secondary to superimposed metallic components.No detected periprosthetic lucencies.No detected fracture of the bones.Visual examination of the provided pictures identified blood on the liner damaged device component likely from removal.Device history record was reviewed and no discrepancies were found.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.
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.The following sections were updated: b4, b5, e1, g4, g7, h1, h2, h6, h10.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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.Investigation and x-ray review on linked complaint determined the revision was due to disassociation between the pm glenoid and taper, with dislocation being secondary.This complaint was only to house the legacy zimmer liner, which is not relevant to the disassociation failure mode.Therefore, this event has been deemed not reportable and not a complaint.This investigation has been completed under medwatch: 0001825034-2020-03470.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: POLY LINER PLUS 0 MM OFFSET 36 MM DIAMETER
• Common Device Name: EXTREMITIES, IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10511552
• Report Number: 0001822565-2020-03189
• Device Sequence Number: 11080236
• Product Code: KWS
• UDI-Device Identifier: 00889024269057
• UDI-Public: (01)00889024269057
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K130661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/10/2022

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 Expiration Date: 08/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 00434903600
• Device Lot Number: 64008392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 10/07/2020; 10/20/2020; 06/08/2022
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 10/23/2020; 10/29/2020; 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown