MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 S-ROM HEAD FEMORAL COCR 32+9; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Catalog Number 875956

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Pain (1994); Burning Sensation (2146); Hypoesthesia (2352); Test Result (2695)

Event Type  Injury  

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 related reported incidents against the provided product code/lot number combination since release for distribution.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Occupation is a non-healthcare professional.

Event Description

Ppf alleges elevated metal ions after the first revision.Doi: (b)(6) 2016.Dor: none.Reported (left hip, second event).

• Brand Name: S-ROM HEAD FEMORAL COCR 32+9
• Type of Device: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6107428552
• MDR Report Key: 9495267
• MDR Text Key: 174602744
• Report Number: 1818910-2019-124043
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295218869
• UDI-Public: 10603295218869
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K920317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/02/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 875956
• Device Lot Number: 8073330
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2015
• 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
• Patient Outcome(s): Other