MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS POROUS STEM 15.5X125MM STR; LPS AND S-ROM : KNEE STEMS

Catalog Number	198726414
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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
During an lps proximal femur replacement the guidelines in the surgical technique were not detailed enough to ensure confident preparation for a porous coated stem with mbt revision reamers that are packed routinely with the lps kit.There is a nb: in the surgical technique to caution that the mbt revision reamers are 0.4mm undersized.These reamers are available in whole numbers only (12, 13 etc).The porous stems are available in sizes 12.5, 13.5 etc.It is recommended to ream for 0.5 mm press-fit or line-to-line in soft bone.During this case using an mbt reamer, the canal was prepared with a 16 mm mbt reamer giving a 0.9 mm press fit with 16.5 mm stem or over-reamed by 0.1 mm for a 15.5 mm stem.To be cautious, a 15.5 mm stem was the first choice of implant to reduce risk of fracture, this stem was undersized.The final definitive implant successfully implanted was a 16.5 stem.The notes in the surgical technique were inadequate to confidently and successfully prepare the femur in the first instance.
Additional Manufacturer Narrative
Product complaint (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: LPS POROUS STEM 15.5X125MM STR
• Common Device Name: LPS AND S-ROM : KNEE STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9084387
• Report Number: 1818910-2019-105336
• Device Sequence Number: 14153734
• Product Code: JDI
• UDI-Device Identifier: 10603295079293
• UDI-Public: 10603295079293
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2019

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 Catalogue Number: 198726414
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1