MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 5; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: femoral component option size e right item# 00595601502 lot# 63957962.Articular surface regular constraint item# 90597004010 lot# 63952346.Unknown optipac with refobacin.All poly patella standard size 35 mm diameter 9.0 mm thickness cemented item# 00597206535 lot# 63984274.Report source - (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.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 a study patient is scheduled for a revision due to tibial loosening.Tibial baseplate loosening was noted approximately nine and a half months¿ post implantation.There is no additional information available at this time.
Additional Manufacturer Narrative
Upon receipt of additional information it was determined that this item was reported in error.The initial report was submitted in error and should be voided.Additional information received indicates that the patient was revised due to an infection that occurred more than one year post implantation which led to loosening.Infection beyond one year of implantation can reasonably be excluded as a contributing facture because infections occurring more that one year after implantation are usually hematogenous.
Event or Problem Description
Upon receipt of additional information it was determined that this item was reported in error.The initial report was submitted in error and should be voided.Additional information received indicates that the patient was revised due to an infection that occurred more than one year post implantation which led to loosening.Infection beyond one year of implantation can reasonably be excluded as a contributing facture because infections occurring more that one year after implantation are usually hematogenous.

• Brand Name: STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 5
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 10453663
• Report Number: 0002648920-2020-00387
• Device Sequence Number: 19746926
• Product Code: JWH
• UDI-Device Identifier: 00889024218857
• UDI-Public: (01)00889024218857
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2020

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 Model Number: N/A
• Device Catalogue Number: 00598604701
• Device Lot Number: 63905965
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 09/25/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR
• Patient Weight: 85