MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER HUMERAL HEADS

Catalog Number UNK SHOULDER HUMERAL HEAD

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

Patient Problems Foreign Body Reaction (1868); Pain (1994); Test Result (2695); No Code Available (3191)

Event Date 02/05/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The article¿s purpose was to report a case of metallosis following a shoulder hemiarthroplasty with a humeral component resurfacing shoulder replacement.The initial implant used in an (b)(6) woman was a depuy global cap resurfacing shoulder hemiarthroplasty for osteoarthritis.After five years, she presented with right shoulder pain.Her background was generalized osteoarthritis with multiple large joint replacements including bilateral hips, knees and left total shoulder replacement.The primary procedure was performed in 2006 to alleviate an intermittently painful and stiff right shoulder which she suffered with over the preceding five years.The depuy global hemi cap resurfacing shoulder used was manufactured from a cobalt chromium molybdenum (cobalt chrome) allow with a porous coated bead in growth surface that is further treated with plasma sprayed hydroxyapatite.Her post-operative recovery was satisfactory.She was referred for further opinion and management of her right shoulder pain.Further testing by radiograph, ct scan and blood test revealed superior subluxation of the humeral component with respect to the glenoid and a normal white cell count.In 2013 she had a revision to a reverse shoulder arthroplasty with a depuy delta xtend shoulder system.The primary intra-operative finding was tissue staining consistent with metallosis.There was surrounding inflammatory and granulomatous tissue.The prosthesis was still fixed.The rest of the procedure had no complications and the retrieved implant was sent for analysis.Evaluation of the device incorporated the following: qualitative macro analysis of the component in terms of degradation mechanisms and metal loading of the intra-operative tissue biopsy sample.Assessment of the intra-operative tissue biopsy revealed 835 ppm of cobalt, and 926 ppm of chromium, which is considered highly elevated compared to normal levels associated with arthroplasty.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.

• Brand Name: UNKNOWN SHOULDER HUMERAL HEADS
• Type of Device: SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 46581-0988 ; 6103142063
• MDR Report Key: 9328129
• MDR Text Key: 183041068
• Report Number: 1818910-2019-114022
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2019

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 Catalogue Number: UNK SHOULDER HUMERAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2019
• Initial Date FDA Received: 11/15/2019
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention