MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPRESS HA ANTI-ROTATION SPINDLE; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Swelling (2091); Limited Mobility Of The Implanted Joint (2671)

Event Date 06/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: oss mod tib baseplate catalog # 150421 lot # 114620, cps anchor plug catalog # 178412 lot # 721820, compress segmental distal femur catalog # 178713 lot # 578330, oss locking pin catalog # 150478 lot # 581520, oss axle catalog # 150480 lot # 543390, oss reinforced yoke catalog # 150493 lot # 405870, refobacin bc r 1x40 us catalog # 110034355 lot # 745eah2108, refobacin bc r 1x40 us catalog # 110034355 lot # 745eah2108, oss 3cm osseoti prox tib slv catalog # 151816 lot # 398650, cps nut co-cr-mo alloy catalog # 178512 lot # 099440, cps centering sleeve 24mm catalog # 178546 lot # 515140, oss tibial poly bearing 18mm catalog # 150413 lot # 037130, oss poly tibial bushing catalog # 150476 lot # 204820, oss poly femoral bushings 2pk catalog # 150477 lot # 326430, clearmix single double mix catalog # 414701 lot # 19585, cps transverse pin 6pk catalog # 178529 lot # 398650.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034 - 2019 - 02699, 0001825034-2019-02704, 0001825034-2019-02705, 0001825034-2019-03222, 0001825034-2019-03224, 0001825034-2019-03225, 0001825034-2019-03226.Remains implanted.

Event Description

It was reported that the patient underwent a left knee arthroplasty.Subsequently, the patient suffered pain and was experiencing loosening post operative.No revision procedure has been reported to date.

Event Description

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

Manufacturer Narrative

Udi #: (b)(4).Customer has indicated that the product will not be returned because product location is unknown.Reported event was confirmed by review of medical records provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Medical record review indicates that the patient had the most recent revision on (b)(6), 2018.The patient had been revised multiple times, since the initial left tha in 2002, in 2007, 2009, 2011, and 2012.The patient had spacer implanted in (b)(6) 2018.The patient had worsening deformity, limitations, and loosening of the most recent revision.X-ray from (b)(6), 2019 showed tha with surrounding bony destruction and deformity.Revision op notes dated (b)(6), 2018 demonstrated that the patient was revised due to loosening.The spacer was removed and new implants implanted.The patient underwent amputation on (b)(6) 2019.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.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

From additional information received, it was reported that the patient underwent an amputation of the left leg due to fracture of the stem prosthesis.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

From additional information received from patient¿s medical records, it was indicated that the patient experienced tenderness, pain, worsening deformity, limitations, loosening, instability, noise, and swelling prior to amputation of the left lower leg.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

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

Event Description

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

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.Medical records review indicates that the patient presents for follow up with tenderness to palpation, pain, and swelling of the left knee.He has had a worsening deformity, limitations, and loosening of his most recent revision.Review of x-rays from (b)(6) 2019 reveals revision tka with surrounding bony destruction and deformity.Increase pain, and gross instability, images indicate mechanical failure between compressed femoral attachment point and distal femur.Components removed easily as was loose proximally and disarticulated.Additional information does not affect the root cause.

• Brand Name: COMPRESS HA ANTI-ROTATION SPINDLE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8824888
• MDR Text Key: 152168868
• Report Number: 0001825034-2019-03223
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: K101475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/22/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 178358
• Device Lot Number: 302330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 07/24/2019
• Supplement Dates Manufacturer Received: 07/11/2019; 01/20/2020; 07/10/2020; 09/10/2020; 12/17/2020
• Supplement Dates FDA Received: 08/06/2019; 01/24/2020; 07/28/2020; 09/25/2020; 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 94