MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ART. SURFACE, 10MM FEM SZ F; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical product: stem extension offset, item# 00598802013, lot# 64168650; tibial component precoat, item# 00588000600, lot# 64347111; all poly patella size 32 mm dia.Standard, item# 00597206532, lot# 63710281; femoral component, item# 00588001601, lot# 63422145; stem extension straight long, item# 00598801118, lot# 62729946; distal femoral augment block precoat, item# 00599003620, lot# 62238678; tibial half block augment tapered precoat w/screws, item# 00598800628, lot# 61999069; tibial half block augment tapered precoat w/screws, item# 00598800638, lot# 62415736.Report source- (b)(6).Customer has indicated that the product will 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.
Event or Problem Description
It was reported that a patient was revised approximately six weeks post implantation due to the hinge-post backing out and inlay subluxation.Patient complained about pain since implantation.There is no additional information at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported event was able to be confirmed by visual examination of the provided images.Images confirmed that the hinge pin post had backed out and the inlay subluxed.X-rays were also provided and reviewed, identifying that the screw had unscrewed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported event is attributed to an outdate surgical technique being use to complete the surgery.The referenced surgical technique does not need to be updated as a more recent surgical technique for the product had been released with the correct information prior to the surgery taking place.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 is being submitted to relay additional information.Receipt of additional information of why the surgeon chose the wrong technique identified a difference to our previous response.The surgeon is a high volume user, well aware of standard technique for rhk and has a standard practice to use the 130in-lbs torch wrench.The error of the incorrect picture was identified by zimmer biomet during a review of investigation and did not impact the surgeons decision.The picture for illustration purpose only shows a 95in-lbs torch however; the directions for use state the correct recommendation of use at 130in-lbs in which the surgeon performed.With the new information, 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 was revised approximately six weeks post implantation due to the hinge-post backing out and inlay subluxation.Patient complained about pain since implantation.

• Brand Name: ART. SURFACE, 10MM FEM SZ F
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9220732
• Report Number: 0001822565-2019-04513
• Device Sequence Number: 2158079
• Product Code: KRO
• UDI-Device Identifier: 00889024199446
• UDI-Public: (01)00889024199446
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K013385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00588006010
• Device Lot Number: 63843292
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 02/24/2020; 03/27/2020
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 02/27/2020; 04/20/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 116