MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK 10.0MM STD OFFSET; OTHER PRODUCTS

Catalog Number 101201100

Device Problem Malposition of Device (2616)

Patient Problems Edema (1820); Pain (1994); Tissue Damage (2104); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 04/05/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).Occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation alleges that patient suffered from severe pain and discomfort in his left hip.The pain has been continuous and has significantly interfered with his normal daily activities.Doi: (b)(6) 2006 - dor: (b)(6) 2010 (right hip).Part/lot information was identified.Records are available if needed for further review.Medical records confirm the product placement in the right hip.Update ad 20 jun 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets record.Ppf has no new allegation.Added facility name, lawyer, products expiration and udi.Doi: (b)(6) 2006 - dor: (b)(6) 2010 (right hip).Patient is bilateral, please see (b)(4) for the left hip.

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.

• Brand Name: TRI-LOCK 10.0MM STD OFFSET
• Type of Device: OTHER PRODUCTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9860318
• MDR Text Key: 189841334
• Report Number: 1818910-2020-08747
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K984740
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/11/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 101201100
• Device Lot Number: TT5F71001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 72