MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD LEFT SIZE 8; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple mdrs were filed for this event.Please see associated: 3007963827 - 2019 - 00304, 0002648920 - 2019 - 00768, 0002648920 - 2019 - 00767, 3007963827 - 2019 - 00302.Concomitant medical products: 42512400714, articular surface fixed bearing posterior stabilized, 64363834.42540200038, all-poly patella cemented 38 mm diameter, 64333036.42540200035, all-poly patella cemented 35 mm diameter, 64435171.42500606401, femur cemented posterior stabilized (ps) standard left size 8, 64295001.42532007101, natural tibia cemented 5 degree stemmed left size e, 64293405.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 during the distribution process packaging damage with sterility barrier potentially compromised was identified.No patient or surgical involvement.No further information available at this time.
Event or Problem Description
No further information is available at the time of this reporting.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported packaging damage event was confirmed via visual examination.It was identified the packaging was damaged in transit.Device history record (dhr) review was performed with no related manufacturing deviations or anomalies identified.Root cause is attributed to transit damage.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.

• Brand Name: FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD LEFT SIZE 8
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 9225246
• Report Number: 3007963827-2019-00303
• Device Sequence Number: 460041
• Product Code: JWH
• UDI-Device Identifier: 00889024229235
• UDI-Public: (01)00889024229235
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42500606401
• Device Lot Number: 64295001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 12/03/2019
• 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