MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Naturally Worn (2988)

Patient Problems Pain (1994); Tissue Damage (2104); Anxiety (2328); Injury (2348); Depression (2361); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 03/27/2017

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Device was used for treatment, not diagnosis. 510k: this report is for an unknown device/unknown lot. Part and lot number are unknown; udi number is unknown. (b)(4).

Event Description

Pinnacle mom litigation records received. Litigation alleges popping, pain, injuries, lack of mobility, emotional distress, anxiety, depression, disability and elevated metal ion levels. However, lab result shows metal ion levels were below 7ppb. It was also stated that the patient was revised to address mechanical complications and bearing surface wear resulting to metallosis. Revision note reported some grayish staining within the trochanter bursa region and some bone type tissue forming between the metal liner and shell. Doi: (b)(6) 2007; dor: (b)(6) 2017; right hip.

Event Description

Ppf alleges abductor muscle repair.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 8390747
• MDR Text Key: 137837513
• Report Number: 1818910-2019-86452
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/05/2019 Patient Sequence Number: 1