MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX NEUT 40IDX74OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1221-40-074
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/20/2020
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
During a revision surgery reported on (b)(4) the patient's femur was fractured.A prostalac stem was implanted.It was reported that they called 1-2 hours later to inform they missed canal, bringing patient back to surgery where 40 grams of new cement was mixed and the stem recemented.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Patient code: no code available (3191) used to capture the surgical intervention and insufficient information.

• Brand Name: ALTRX NEUT 40IDX74OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10119111
• Report Number: 1818910-2020-13206
• Device Sequence Number: 11671544
• Product Code: LPH
• UDI-Device Identifier: 10603295393436
• UDI-Public: 10603295393436
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K062148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2020

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 Expiration Date: 11/30/2023
• Device Model Number: 1221-40-074
• Device Catalogue Number: 122140074
• Device Lot Number: J1957N
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 07/16/2020
• 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: ALTRX NEUT 40IDX74OD; PROSTALAC LT 200 STEM SZ3; ALTRX NEUT 40IDX74OD; PROSTALAC LT 200 STEM SZ3
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 62