MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS CEMENTED STEM 10X100MM STR; LPS AND S-ROM : KNEE STEMS

Model Number	1987-25-110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/22/2020
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
It was reported by the sales representative that the patient has reported with a fractured lps in situ, 1.5cm below stem collar.The last operation - 2017 for cup revision only, lps already in situ.It is unknown if the prior revision was for depuy products.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.It was possible in review of provided x-ray images to confirm the reported material fracture.It was not possible to determine the root cause using images only.A review of device manufacturing records finds no deviations or anomalies.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : lot 509282.A review of device manufacturing records finds no deviations or anomalies.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: lot 509282.A review of device manufacturing records finds no deviations or anomalies.A review of device manufacturing records found no deviations or anomalies.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.It was possible in review of provided x-ray images to confirm the reported material fracture.It was not possible to determine the root cause using images only.A review of device manufacturing records finds no deviations or anomalies.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : lot 509282.A review of device manufacturing records finds no deviations or anomalies.

• Brand Name: LPS CEMENTED STEM 10X100MM 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: 10815945
• Report Number: 1818910-2020-24276
• Device Sequence Number: 1127616
• Product Code: JWH
• UDI-Device Identifier: 10603295079149
• UDI-Public: 10603295079149
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K003182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• 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,Followup,Followup
• Report Date (Section B): 10/23/2020

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: 1987-25-110
• Device Catalogue Number: 198725110
• Device Lot Number: 509282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 01/07/2021; 03/15/2021; 05/12/2021
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 01/11/2021; 03/30/2021; 05/17/2021
• 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: DELTA CER HEAD 12/14 32MM +1; LPS PROX FEM TROC BODY NEUTRAL; LPS SEGMENTAL COMPONENT 65MM; PINN MAR +4 10D 32IDX48OD; PINN SECTOR W/GRIPTION 48MM; DELTA CER HEAD 12/14 32MM +1; LPS PROX FEM TROC BODY NEUTRAL; LPS SEGMENTAL COMPONENT 65MM; PINN MAR +4 10D 32IDX48OD; PINN SECTOR W/GRIPTION 48MM
• Outcome Attributed to Adverse Event: Required Intervention