MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM STD,36NK,20X15X165; HIP FEMORAL STEM

Catalog Number	523194
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Tissue Damage (2104); Distress (2329); Discomfort (2330); Injury (2348); Not Applicable (3189); No Code Available (3191)
Date of Event	01/08/2018
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.
Event or Problem Description
Patient was revised to address groin pain, bone injury, soft tissue injury, discomfort, and metal poisoning.Doi: (b)(6) 2010.Dor: (b)(6) 2018; left hip.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Udi: (b)(4).
Event or Problem Description
Ppf alleges loosening of cup and metal wear.

• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0899
• MDR Report Key: 7446551
• Report Number: 1818910-2018-57933
• Device Sequence Number: 2052679
• Product Code: JDI
• UDI-Device Identifier: 10603295170884
• UDI-Public: 10603295170884
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2018

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: 01/21/2015
• Device Catalogue Number: 523194
• Device Lot Number: 3062596
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 08/06/2018; 12/19/2018
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 08/30/2018; 12/27/2018
• 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: 61 YR