MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS DIAPHYSEAL LOCKING SCREW SET; SHOULDER PROSTHESIS

Model Number N/A

Device Problem Noise, Audible (3273)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: oss segmental femoral component, catalog # 150355, lot # 267280; oss tibial bearing, catalog # 150411, lot # 312720; oss femoral bushings set, catalog # 150477, lot # 040920; oss femoral bushings set, catalog # 150477, lot # 918980; oss yoke, catalog # 150493, lot # 991160; oss tibial bushing, catalog # 150476, lot # 581390; oss non-modular long tibial baseplate, catalog # 161043, lot # 068050; compress device segmental anchor plug, catalog # 178402, lot # 930680; compress transverse pin, catalog # 178527, lot # 785050; compress anti-rotation spindle, catalog # 178354, lot # 925600; compress nut, catalog # 178512, lot # 885860; compress centering sleeve, catalog # 178537, lot # unknown; compress taper adapter, catalog # 178711, lot # 755330; oss diaphyseal stacking adaptor, catalog # 150483, lot # 975100; oss diaphyseal segment, catalog # 150465, lot # 414310; oss diaphyseal segment ,catalog # 150464, lot # 556640; oss axle, catalog # 150480, lot # 584290; oss locking pin, catalog # 150478, lot # 210660.Customer has indicated that the product will not be returned because product location is unknown.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: 0001825034-2018-09174, 0001825034-2018-09175, 0001825034-2018-09178, 0001825034-2018-09181, 0001825034-2018-09183, 0001825034-2018-09418, 0001825034-2018-09420, 0001825034-2018-09421, 0001825034-2018-09422, 0001825034-2018-09423, 0001825034-2018-09424, 0001825034-2018-09426, 0001825034-2018-09428, 0001825034-2018-09429, 0001825034-2018-09430, 0001825034-2018-09433.Product location is unknown.

Event Description

It was reported that after a patient underwent a knee arthroplasty with a limb salvage system the patient went into deep flexion, against the surgeons orders, and heard an audible popping noise.The patient underwent a revision, during which it was reported that the compress nut was re-tightened and the construct was re-assembled using the same metal components with new polyethylene components.No additional information was provided.

Event Description

Upon receipt of additional information, it was determined that the initial report was submitted in error and should be voided.

Manufacturer Narrative

Upon receipt of additional information, it was determined that the initial report was submitted in error and should be voided.

• Brand Name: OSS DIAPHYSEAL LOCKING SCREW SET
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7934126
• MDR Text Key: 122664748
• Report Number: 0001825034-2018-09425
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: PK020045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• 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: 150481
• Device Lot Number: 133790
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2019
• 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