MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 SROM NRH TIB PLAT ASSY SM 21MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Catalog Number	621613
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Revision of s-rom-noiles knee prosthesis because of fracture of unidentified metal part.Doi: (b)(6) 2012 alio loco, dor: (b)(6) 2018.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: corrected: d10 & h3 product complaint # (b)(4).Investigation summary = > following inspection of the returned products and review of the information received, it was concluded that it was unlikely that a manufacturing defect was present.The complaint shall be closed with an undetermined conclusion; it shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.Device history lot = > null device history batch = > null device history review = > null if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Added: h1.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: d10.Corrected: d4, h3 and h4.
Additional Manufacturer Narrative
There is no new information to report at this time.Per fda request, this follow-up is being submitted to fill the gap in follow-up sequence numbers.
Additional Manufacturer Narrative
Corrected b4, g4.They should have been reported as 03/13/2018 to reflect when the updated information was received.

• Brand Name: SROM NRH TIB PLAT ASSY SM 21MM
• Common Device Name: LPS AND S-ROM : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY RAYNHAM ¿ 1219655 ; 325 paramount drive; raynham IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7396698
• Report Number: 1818910-2018-56695
• Device Sequence Number: 13470314
• Product Code: KRO
• UDI-Device Identifier: 10603295178989
• UDI-Public: 10603295178989
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K011810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2014
• Device Catalogue Number: 621613
• Device Lot Number: P0409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female