MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PRODIGY LG STAT SHT LT 12.0MM; PRODIGY HIP STEM : HIP FEMORAL STEM

Catalog Number 152046050

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Pain (1994); Osteolysis (2377); Joint Laxity (4526); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/07/2016

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation and medical records received.After review of medical records.It was reported that the patient was complaining of significant pain, as well as elevated indices in regard to her metal-on-metal evaluation.The patient was then revised for failed left tha.Operative notes reported that surgeon removed that femoral head and sleeved over the trunnion, there was significant metal on metal debris.There was approximately 20 ml of dark brown fluid that was aspirated.There had very minimal, if any, ingrowth bone on the cup.After the cup was removed, patient did have a significant inferior lysis as well as metal on metal debris in that region as well as significant anterior capsular as well as psoas tendon metal on metal reaction.Patient also has a fair amount of bleeding, which was controlled bovie as well as aquamantys.Doi: (b)(6) 2009, dor: (b)(6) 2016, left hip.

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 : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Device history review : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

Event Description

In addition to what were previously reported and after review of the medical records, the patient was revised to address mom failed left tha and instability.Operative note reported significant instability.Doi: (b)(6) 2009, dor: (b)(6) 2016, left hip.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

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: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: PRODIGY LG STAT SHT LT 12.0MM
• Type of Device: PRODIGY HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11615048
• MDR Text Key: 243815307
• Report Number: 1818910-2021-07017
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K150862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 152046050
• Device Lot Number: C2BBJ1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 54; ASR UNI FEMORAL IMPL SIZE 47; PRODIGY LG STAT SHT RT 10.5MM; ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 54; ASR UNI FEMORAL IMPL SIZE 47; PRODIGY LG STAT SHT RT 10.5MM
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR