MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STEM EXTENSION OFFSET 11MM DIA X 100MM LENGTH; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Reaction (2414)
Date of Event	02/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2019-01178, 0002648920-2019-00213.Articular surface with locking screw item# 00599404012 lot# 63533554, stemmed tibial component precoat item# 00598004701 lot# 63669686, femoral component size f right item# 00599401692 lot# 63709723, stem extension straight 16mm dia x 100mm l item# 00598801016 lot# 63612046.The reported event was confirmed as articular surface and supporting screw were returned and visual evaluation of the returned product exhibits signs of wear (nicked, gouged, micro motion).The threads on the tip of the supporting screw was found slightly damaged.Initial op notes and first revision surgery op notes were not provided.Second revision op notes demonstrated that the patient was revised due to pain and instability.During the revision, in the area of the medial collateral ligament, there is evidence of few but existing mild changes due to metallosis.The screw was disassociated and removed.A new articular surface with the same size was implanted.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot 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
It was reported that a patient underwent an initial knee procedure and subsequently the patient was revised due to loosening of the fixation screw of the inlay.No additional information is available.

• Brand Name: STEM EXTENSION OFFSET 11MM DIA X 100MM LENGTH
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9266661
• Report Number: 0001822565-2019-04681
• Device Sequence Number: 16606777
• Product Code: JWH
• UDI-Device Identifier: 00889024221444
• UDI-Public: (01)00889024221444
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K933785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/01/2019

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 Model Number: N/A
• Device Catalogue Number: 00598802011
• Device Lot Number: 63725407
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/01/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 101