MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SROM STM STD 36+12L 17X22; HIP FEMORAL STEM/SLEEVE

Catalog Number	563622
Medical Device Problem Codes	Corroded (1131); Malposition of Device (2616)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848); Hematoma (1884); Pain (1994); Swelling (2091); Discomfort (2330); Injury (2348); Joint Disorder (2373); Joint Dislocation (2374); Not Applicable (3189)
Date of Event	01/16/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
Event or Problem Description
Patient was revised to address a painful hip.Update nov 14, 2017: pfs and medical records received.Litigation alleges right hip pain, popping in the right hip, discomfort and instability when walking.After review of medical records for mdr reportability it was reported that the patient was revised to address multiple dislocation.Revision note states, the trunnion was clean and intact with minimal corrosion on the trunnion.It also showed that the stem was in about 15 degrees of anteversion.Added unknown stem for the corrosion and complainant information.This complaint was updated on nov 29, 2017.Update nov 30, 2017: pfs and medical records received.There is no new information added.This complaint was updated on: dec 12, 2017.
Event or Problem Description
Ppf, pfs and medical records received.Ppf and pfs alleges pain, discomfort,instability when walking, popping in the right hip and multiple right hip dislocation.After review of medical records for mdr reportability, the patient was revised to address dislocation of hip joint prosthesis.Revision notes reported minimal corrosion on the trunnion and the stem showed about 15 degrees of anteversion.Clinic visit stated that the patient had fall, pain, swelling, bruising, hematoma and hip injury.
Additional Manufacturer Narrative
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.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SROM STM STD 36+12L 17X22
• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7116551
• Report Number: 1818910-2017-29700
• Device Sequence Number: 13677903
• Product Code: JDI
• UDI-Device Identifier: 10603295178248
• UDI-Public: 10603295178248
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/14/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2015
• Device Catalogue Number: 563622
• Device Lot Number: 2533613
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 12/15/2017; 04/10/2018; 09/17/2019
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 01/02/2018; 05/01/2018; 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 115