MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 LPS POROUS STEM 12.5X100MM STR; LPS AND S-ROM : KNEE STEMS

Catalog Number	198726111
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
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
On (b)(6) 2018 sales rep (b)(6) came to know through dr (b)(6), (b)(6) hospital about a complaint for broken implant.A patient with lps implant done few years back has come back with broken stem.Complete history not known operated at (b)(6) hospital few years back.
Event or Problem Description
It was reported that the surgery was delayed to find any broken implant in patient.It was revised as during reduction after final implantation came out.
Additional Manufacturer Narrative
Product complaint # = > pc-(b)(4).
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Pc-(b)(4).No device associated with this report was received for examination.Provided x-ray images confirmed the reported event.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LPS POROUS STEM 12.5X100MM STR
• Common Device Name: LPS AND S-ROM : KNEE STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7695818
• Report Number: 1818910-2018-64633
• Device Sequence Number: 1015709
• Product Code: JDI
• UDI-Device Identifier: 10603295079255
• UDI-Public: 10603295079255
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K033959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/02/2018

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 Catalogue Number: 198726111
• Device Lot Number: ET5K81000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2018
• Supplement Date Received by Manufacturer: 07/26/2018; 08/07/2018; 09/07/2018; 10/02/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 08/02/2018; 08/08/2018; 09/28/2018; 10/15/2018
• 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