MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VIVACIT-E DM LINER 28 X 38MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: g7 pps ltd acet shell 48c cat# 010000661 lot# 6630012; g7 dual mobility liner 38mm c cat# 110024461 lot# 621630; femoral stem 12/14 neck taper plasma sprayed cat# 00771100910 lot# 64725469; bioloxâ® delta, ceramic femoral head cat# 00877502801 lot# 2971489; prem st/g7 cp/e1 aa dm ln cer cat# 98800102505 lot#unk.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to a manufacturing deficiency.This event is being farther investigated through the capa process.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
It was reported that during total hip arthroplasty the wrong size part was in the package and implanted.No additional information.
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.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient demonstrates good balance and ambulates around her house remarkably well considering obstacles and clutter that requires maneuvering around.Patient continues to mitigate pain through ice and pain medicine occasionally.Patient is no longer taking oxycodone and is taking tylenol or tramadol.Patient spoke with doctor regarding her difficulty complying with hip precautions.According to patient, doctor said just be very careful.Reports she has cellulitis in her left leg and was prescribed bactrim.Increased redness and swelling of lle as a result of cellulitis.Patient reported her visit findings from dr.(b)(6).According to patient she will be having knee incision re-sutured, and then at a later date will be having her hip replacement replaced.Pt stated she had a fall over a chair in home resulting in opening in incision of l knee and 2 rib fx.Pt stated she saw dr.(b)(6) today and is scheduled for quick surgical repair of l knee to close wound on (b)(6) 2020.Pain 2/10 with certain movements, patient met all functional pt goals, discharged from pt.Left hip revised, patient discharged home.Home pt scheduled.Patient demonstrates good dynamic balance as evidenced by independence with adls.However, patient is non-compliant with hip replacement precautions.Reviewed precautions and adaptive equipment but patient reports she will most likely remain non-compliant.Patient demonstrated satisfactory progress with pt, reports intermittent pain at 4/10 with certain activities, demonstrates proper gait, balance, and mobility without complication, reports generalized fatigue and weakness but is likely attributed to physical and mental comorbidities unrelated to the hip.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to a manufacturing deficiency.A corrective action has been initiated to resolve the issue.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: diagnosis: left femoral neck fracture, osteoarthritis.Procedure: lt tha.General anesthesia, ebl: 200, no complications.Leg lengths re-established, excellent fit of stem & axial torsional stability with implants, hip stable in rom.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to a manufacturing deficiency.A corrective action has been initiated to address this issue.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.
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.H6 - device code - device migration (4003) was initially reported; however, after further review, it was determined this code was reported in error and does not apply.Please remove.
Event or Problem Description
It was reported that during total hip arthroplasty the wrong size part was in the package and implanted.The patient was revised 3 months later with correct implants.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual review of the device shows no damage to the liner.Item and lot are not etched on the device and unable to be confirmed.The product identifier for overall height and width were measured and show the device non conforming to specification.The dimensions for product identifiers do however fall within specification for a 42mm liner.Device history record (dhr) 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.

• Brand Name: VIVACIT-E DM LINER 28 X 38MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10501688
• Report Number: 0001822565-2020-03152
• Device Sequence Number: 11558982
• Product Code: LPH
• UDI-Device Identifier: 00889024572676
• UDI-Public: (01)00889024572676(17)250531(10)64755636
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K190656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/22/2021

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 Expiration Date: 05/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 110031009
• Device Lot Number: 64755636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 11/04/2020; 11/17/2020; 12/11/2020; 12/17/2020; 01/21/2021
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 11/05/2020; 12/09/2020; 12/14/2020; 01/15/2021; 01/22/2021
• 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
• Patient Weight: 45