MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT DUOFIX TAP SZ8 HI OFF; HIP FEMORAL STEM/SLEEVE

Model Number 1570-12-150

Device Problems Corroded (1131); Degraded (1153)

Patient Problems Adhesion(s) (1695); Fatigue (1849); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Osteolysis (2377); Impaired Healing (2378); Limited Mobility Of The Implanted Joint (2671); Swelling/ Edema (4577)

Event Date 06/02/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Aug 17, 2017: legal medical records received.Litigation alleges fatigue, pain, clicking sensation, limited mobility, high cobalt levels, infection, and pathology reports confirmed presence of propionibacterium acnes.After review of medical records for mdr reportability, it was stated that the patient was revised to address infection.Revision notes reported necrosis, purulent appearing fluid, synovial type lining and granulation tissue which appears very thickened, reddened and abnormal, small amount of residual corrosion on the taper, large lytic defect.Pathologist describes increased acute inflammation all consistent with infection.Mri shows hyperintense osteolysis.Laboratory results for cobalt-chromium showed below 7ppb.Part and lot information for head and liner were provided but not readable.

Manufacturer Narrative

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

Manufacturer Narrative

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.Udi: (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.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: null.Device history batch: null.Device history review: null.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 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: e3 initial reporter occupation: lawyer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Revision operative notes 02 jun 2017 indicated that the patient received a left total hip revision due to delay wound healing and infection.Upon entering the joint necrotic tissue, inflammed tissue, and purulent fluid was encountered and removed.Osteolysis was noted on the acetabular side and was debrided.The stem was noted to have a small amount of corrosion.All implants were removed and prostalac was placed for infection treatment.The surgery was completed without indication of complication by the surgeon.

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

Event Description

Revision operative notes (b)(6) 2017 indicated that the patient received a left total hip revision due to delay wound healing and infection.Upon entering the joint necrotic tissue, inflammed tissue, and purulent fluid was encountered and removed.Osteolysis was noted on the acetabular side and was debrided.The stem was noted to have a small amount of corrosion.All implants were removed and prostalac was placed for infection treatment.The surgery was completed without indication of complication by the surgeon.

• Brand Name: SUMMIT DUOFIX TAP SZ8 HI OFF
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 6869291
• MDR Text Key: 86330551
• Report Number: 1818910-2017-24825
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 10603295060192
• UDI-Public: 10603295060192
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2018
• Device Model Number: 1570-12-150
• Device Catalogue Number: 157012150
• Device Lot Number: CP8FR1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2008
• 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: ALTRX +4 10D 36IDX62OD; ALTRX +4 10D 36IDX62OD; APEX HOLE ELIM POSITIVE STOP; APEX HOLE ELIM POSITIVE STOP; DLT TS CER HD 12/14 36MM +5.0; DLT TS CER HD 12/14 36MM +5.0; PINNACLE 100 HA ACET CUP 62MM; PINNACLE 100 HA ACET CUP 62MM
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 127 KG