MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK TI 17.5 LAT OFFSET; HIP FEMORAL STEM/SLEEVE

Catalog Number 101212175

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Swelling (2091); Weakness (2145); Discomfort (2330); Malaise (2359); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: (b)(4).The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.(b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.

Event Description

Pfs and medical records received.After review of the pfs and medical records for mdr reportability, primary surgical notes were provided for the left hip.Litigation is for the right hip and they alleged pain, discomfort, inflammation, elevated metal ion levels, pain when moving, limp, and the sensation of weakness or the hip giving out on him.Metal ion levels provided were non-reportable, below the 7ppb.This com is for the left hip.Update rec'd 03/09/2017 litigation documents received.Litigation alleges patient suffers from extreme pain, discomfort, soreness; malaise; swelling; loss of energy; immobilization and both acute localized damage to tissue and/or bone surrounding the acetabulum.

Manufacturer Narrative

Additional narrative: pfs and medical records received.After review of the pfs and medical records for mdr reportability,primary surgical notes were provided for the left hip.Litigation is for the right hip and they alleged pain, discomfort, inflammation, elevated metal ion levels, pain when moving, limp, and the sensation of weakness or the hip giving out on him.Metal ion levels provided were nonreportable, below the 7ppb.This com is for the left hip.The reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.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.

Manufacturer Narrative

(b)(4).

Event Description

The patient's initials was updated.The patient underwent bilateral total hip arthroplasty.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa- (b)(4).Ongoing post market surveillance is conducted per our procedures for this product.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TRI-LOCK TI 17.5 LAT OFFSET
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 6435070
• MDR Text Key: 70859707
• Report Number: 1818910-2017-15336
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K872878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 101212175
• Device Lot Number: ZK1FVA000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 73