MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PRODIGY SM STAT SHT LT 10.5MM; PRODIGY HIP STEM : HIP FEMORAL STEM

Catalog Number 152012000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Erythema (1840); Hemorrhage/Bleeding (1888); Unspecified Infection (1930)

Event Date 09/11/2006

Event Type  Injury  

Event Description

Revision completed due to infection.Patient complained of reddened area around incision site.The patient was then revised due to infected left tha.Operative notes reported that there appeared to be purulent material in all areas even contacting the metal on the implants.It was also indicated that the patient received 4 u prbc.Doi: (b)(6) 2003; dor: (b)(6) 2006 left hip.

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.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: g2 .If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: a1, e1, e2, e3.E3 initial reporter occupation: lawyer.

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.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: PRODIGY SM STAT SHT LT 10.5MM
• Type of Device: PRODIGY HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13735225
• MDR Text Key: 287023210
• Report Number: 1818910-2022-04540
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 152012000
• Device Lot Number: V1YC11005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/11/2022
• Supplement Dates Manufacturer Received: 03/14/2022; 03/29/2022
• Supplement Dates FDA Received: 03/17/2022; 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2001
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP.; ARTICULEZE M HEAD 36MM +8.5.; ARTICULEZE M HEAD 36MM +8.5.; PINNACLE 100 ACET CUP 52MM.; PINNACLE MTL INS NEUT36IDX52OD.
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female