MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS CEMENTED STEM 12X125MM STR; LPS AND S-ROM : KNEE STEMS

Model Number	1987-25-412
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	07/22/2021
Type of Reportable Event	Serious Injury
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
It was reported that the implanted lps stem at femur has been broken.The x-ray showed that the implant and bone both fractured.Dor: (b)(6) 2021.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available x-rays were reviewed, and evidence of implant fracture was found.The investigation regarding the lps cemented stem 12x125mm str with lot number j46k66 found no other occurrences like this event, suggesting not a malfunction on the device.The device must have been submitted to a trauma force big enough to cause a traverse fracture on the implant.However without the physical device it is impossible to reach a more thoroughly conclusion.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: LPS CEMENTED STEM 12X125MM 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: 12318719
• Report Number: 1818910-2021-17800
• Device Sequence Number: 4541715
• Product Code: JWH
• UDI-Device Identifier: 10603295079170
• UDI-Public: 10603295079170
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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 Model Number: 1987-25-412
• Device Catalogue Number: 198725412
• Device Lot Number: J46K66
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LPS CEMENTED STEM 12X125MM STR; LPS DISTAL FEM COMP XSM LT; LPS SEGMENTAL COMPONENT 40MM; LPS UNIV TIB HIN INS XSM 14MM; LPS CEMENTED STEM 12X125MM STR; LPS DISTAL FEM COMP XSM LT; LPS SEGMENTAL COMPONENT 40MM; LPS UNIV TIB HIN INS XSM 14MM
• Outcome Attributed to Adverse Event: Required Intervention