MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SUMMIT DUOFIX TAP SZ4 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number	157002100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
Date of Event	06/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).For the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Pfs alleges pain, discomfort, soreness, difficulty walking and standing, difficulty sleeping, limited mobility anxiety, unnecessary surgery and muscle and soft tissue destruction.Added lawyer and law firm.Updated doi.Doi: (b)(6) 2007.Dor: (b)(6) 2016, (right hip).
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: SUMMIT DUOFIX TAP SZ4 STD OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 8901274
• Report Number: 1818910-2019-101322
• Device Sequence Number: 2548584
• Product Code: LPH
• UDI-Device Identifier: 10603295059455
• UDI-Public: 10603295059455
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K001489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2017

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: 03/31/2007
• Device Catalogue Number: 157002100
• Device Lot Number: BH9HG1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 07/30/2019; 11/19/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 08/16/2019; 11/29/2019
• 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: 70 YR
• Patient Weight: 95