MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SERIES A PATELLA STANARD 31 3 PEG; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Pain (1994); Swelling (2091)

Event Date 07/08/2019

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Medical products: bmt 360 tib tray 71mm; p/n: 185203, l/n: unk, vg 360 dst fm ag 67.5x5 rl/lm; p/n: 185305, l/n: unk, vngd ssk psc tib brg 12x71/75; p/n: 183882, l/n: unk, bmt 360 tib sm cruciate wing; p/n: 185650, l/n: unk, bmt splined knee stm v2 15x80; p/n: 148305, l/n: unk , bmt 360 tib 5.0 offset adapter; p/n: 185211, l/n: unk , series a pat std; p/n: 184764, l/n: unk, palacos r 1x40 single; p/n: 00111214001, l/n: unk qty: 3.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.No additional patient consequences were reported.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: 0001825034 - 2019 - 03370 - 1, 0001825034 - 2019 - 03372 - 1, 0001825034 - 2019 - 03373 - 1, 0001825034 - 2019 - 04217, 0001825034 - 2019 - 04218, 0001825034 - 2019 - 04219, 0001825034 - 2019 - 04223.Product location is unknown.

Event Description

It was reported that following a revision procedure, patient is experiencing pain, swelling and falling.No additional patient consequences were reported.

Event Description

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

Manufacturer Narrative

Complaint sample was evaluated via medical records and the reported event was not confirmed.Medical records were provided and reviewed by a health care professional.Patient was revised with no complications noted.Post-revision ultrasound found soft tissue swelling and tendinosis without tear.Patient claims to have tested positive for infection but cannot be confirmed due to lack of medical records.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Updated: a5, b4, b5, d4, d11, g4, g7.Additional: h1, h2, h4, h10.D4 udi: (b)(4).D11 medical products: bmt 360 tib tray 71mm; p/n: 185203, l/n: 737710 vg 360 dst fm ag 67.5x5 rl/lm; p/n: 185305, l/n: 115520 vngd ssk psc tib brg 12x71/75; p/n: 183882, l/n: 246260 bmt 360 tib sm cruciate wing; p/n: 185650, l/n: 727430 bmt splined knee stm v2 15x80; p/n: 148305, l/n: 731620 bmt 360 tib 5.0 offset adapter; p/n: 185211, l/n: 198190 series a pat std; p/n: 184764, l/n: 693590 palacos r 1x40 single; p/n: 00111214001, l/n: unk qty: (b)(4).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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D11: (b)(6)2019 185203 - bmt 360 tib tray - 737710, 185305 - vg 360 dst fm ag - 115520, 183882 - vngd ssk psc tib brg - 246260, 185650 - bmt 360 tib sm cruciate - 727430, 148305 - bmt splined knee stm v2 - 731620, 185211 - bmt 360 tib 5.0 offset - 198190, 148302 - bmt splined knee stm v2 - 139650, 185211 - bmt 360 tib 5.0 offset - 233860, 185265 - vngd ssk 360 femur - 3366083, 00111214001 - palacos single - unknown, 00111214001 - palacos single - unknown, 00111214001 - palacos single - unknown.The following sections were updated: b4; b5; g4; g7; h1; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.No medical records were provided.Medical records were provided and reviewed by a health care professional.Patient was revised with no complications noted.Post-revision ultrasound found soft tissue swelling and tendinosis without tear.Patient claims to have tested positive for infection but cannot be confirmed due to lack of medical records.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03370-4, 0001825034-2019-03372-4, 0001825034-2019-03373-4, 0001825034-2019-04217-3, 0001825034-2019-04218-3, 0001825034-2019-04219-3, 0001825034-2020-02312, 0001825034-2020-02314, 0001825034-2020-02315.

• Brand Name: SERIES A PATELLA STANARD 31 3 PEG
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9105497
• MDR Text Key: 163200642
• Report Number: 0001825034-2019-04223
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K040770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/10/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2021
• Device Model Number: N/A
• Device Catalogue Number: 184764
• Device Lot Number: 693590
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/08/2019
• Initial Date FDA Received: 09/23/2019
• Supplement Dates Manufacturer Received: 11/25/2019; 02/10/2020; 06/08/2020
• Supplement Dates FDA Received: 12/05/2019; 03/04/2020; 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE; SEE H10 NARRATIVE; SEE H10.
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 100