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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Anxiety (2328); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Ambulation Difficulties (2544); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Physical Asymmetry (4573)

Event Date 09/30/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4- the device catalog number is unknown; therefore, udi is unavailable.H10: e3 initial reporter occupation: lawyer.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Asr litigation record received.Litigation alleges pain, discomfort, elevated metal ions, emotional distress, permanent injuries, disability and disfigurement.Doi: (b)(6) 2008; dor: (b)(6) 2022 ; 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; 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.H10 additional narrative: added: a2 (age), b5, b7, d4 (lot, udi), h4, h6 (clinical codes), g4 (pma) corrected: d1, d2a, d2b, d4 (catalog), d6b (removed dor for the stem), d10.

Event Description

Medical records were received and stated the following: the patient was revised to address failed left tha with the development of pseudotumor resulting to pain and walking difficulty.Operative note reported a large amount of red-tinged fluid, wrinkled scar tissue which is consistent for pseudotumor.This was adherent to the deep surface of the gluteus fascia, as well as a secondary pseudotumor distal and lateral on the femur in the region of the lesser trochanter.There was full of scar tissue.Stem was excellent however had some staining but removed easily.There was minimal bone loss.Concern on the stability and leg length discrepancy due to previous head size.Doi: (b)(6) 2008 dor: (b)(6) 2022 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.

Event Description

Asr litigation record received.The litigation alleges pain, discomfort, elevated metal ions, emotional distress, permanent injuries, disability, anxiety, and disfigurement.The patient suffered from elevated cobalt and chromium levels and a pseudotumor.During the revision procedure, the surgeon found metallosis throughout the hip.

• 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
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16918282
• MDR Text Key: 315071708
• Report Number: 1818910-2023-10132
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 152046050
• Device Lot Number: CT6E61000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2008
• 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: ADAPTER SLEEVES 12/14 +5; ASR ACETABULAR CUPS 54; ASR UNI FEMORAL IMPL SIZE 47; PRODIGY LG STAT SHT LT 12.0MM; UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR; UNK HIP FEMORAL SLEEVE ASR
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 80 KG