MAUDE Adverse Event Report: DEPUY IRELAND 9616671 S-ROM*STM STD,36NK,14X09X130; HIP FEMORAL STEM/SLEEVE

Catalog Number	523191
Medical Device Problem Codes	Corroded (1131); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Host-Tissue Reaction (1297); Fatigue (1849); Headache (1880); Pain (1994); Tissue Damage (2104); Injury (2348); Joint Disorder (2373); Ambulation or Postural Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189); No Code Available (3191)
Date of Event	06/02/2016
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 revised to address instability and "hydraulic effect from joint effusion" update nov 21, 2017: litigation record received.Litigation alleges corrosion and friction causing toxic cobalt-chromium metal debris, pain and disability.Added stem for the alleged corrosion.Added new complainant information.This complaint was updated on nov 22, 2017.
Event or Problem Description
Pinnacle pfs and medical records received.Pfs alleges pain, headaches, joint noise, fatigue, limited mobility, walking difficulty, unstable feeling, and muscle loss.After review of medical records for mdr reportability, it was stated that the patient was revised to address instability and subluxation.Revision notes reported that large effusion in the joint appearing bit cloudy thin fluid sometimes with metal reaction, and posteriorly unstable.The surgeon noted that the cup was stable but its position and maybe some hydraulic effect from the joint effusion created the instability issue.Cobalt ion level is above 7 ppb.Added cup since it was revised.Stem was not revised but included in this complaint due to the reported elevated metal ion level.Doi: (b)(6) 2001; dor: (b)(6) 2016; left hip.
Additional 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.

• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy; cork ; EI
• MDR Report Key: 7123052
• Report Number: 1818910-2017-29732
• Device Sequence Number: 1331682
• Product Code: JDI
• UDI-Device Identifier: 10603295170853
• UDI-Public: 10603295170853
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2017

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: 12/01/2004
• Device Catalogue Number: 523191
• Device Lot Number: 651324
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2017
• Supplement Date Received by Manufacturer: 04/13/2018; 06/27/2018
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 04/25/2018; 07/03/2018
• 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: 42 YR
• Patient Weight: 100