MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFCSIG 1PST RD/DOME PAT 32MM; SIGMA KNEE PRIMARY : KNEE PATELLA

Catalog Number	986036
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); Not Applicable (3189)
Date of Event	07/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Patient reported persistent knee cap pain after years of good function.Surgeon suspected loose patella.Loose patella(single peg style) confirmed intraoperatively.It was not grossly loose, but had micro motion per the surgeon.Loosening was at the cement/implant interface.Cement manufacturer is unknown.Dome of patella exhibited a linear band of wear from top to bottom also good bone stock to re cement new 3 peg patella and linear exchanged while in knee.Doi: (b)(6) 2005; dor: (b)(6) 2018; left knee.
Additional Manufacturer Narrative
Product complaint # = > pc-(b)(4).Investigation summary = > no device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate. .

• Brand Name: PFCSIG 1PST RD/DOME PAT 32MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE PATELLA
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7771871
• Report Number: 1818910-2018-66280
• Device Sequence Number: 11016167
• Product Code: NJL
• UDI-Device Identifier: 10603295253105
• UDI-Public: 10603295253105
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 986036
• Device Lot Number: 1870854
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Weight: 92