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

Catalog Number UNK SHOULDER GLENOSPHERE

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

Patient Problems Hematoma (1884); Unspecified Infection (1930); No Code Available (3191)

Event Date 06/08/2013

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.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.(b)(4).

Event Description

The literature article entitled ¿treatment strategies for infection after reverse shoulder arthroplasty¿ by reinhold ortmaier; herbert resch; wolfgang hitzl; michael mayer; ottokar studner; and mark tauber; published in eur j orthop surg tramatol online on june 8, 2013, was reviewed.The article¿s purpose was to report on a retrospective case series to describe specific treatment strategies for deep infection after reverse shoulder arthroplasty.During a 12-year period (between 1998-2010) 192 patients (192 shoulders) were treated with either primary or revision rsa at the authors¿ institution.All procedures were performed by three experienced shoulder surgeons.The institution¿s shoulder database was searched for post-operative rsa infection.There were 21 shoulders in 21 patients treated for deep infection after rsa with a minimum follow-up time of 24 months.Of the 21 patients, one patient died from causes unrelated to the shoulder, which left 20 shoulders in 20 patients (95% follow-up rate).All 20 patients had interventions due to infection.Each patient is broken down with sex, age, treatment and complication (if any).Patient 18, (b)(6) male, two-stage revision, inlay exchange (dislocation), hematoma.

Manufacturer Narrative

Product complaint # (b)(4).(b)(4) used to capture medical device removal.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.Investigation methods: was patient affected: yes.Device history reviewed: no.Lot trace obtained: no.Complaints database searched: no.Product checked: no.Label checked: no.Product pulled from stock for inspection: no a review of complaint databases was not possible as no product details were received.It should be noted that no device was returned.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per (b)(4).

• Brand Name: UNKNOWN SHOULDER GLENOSPHERE
• 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 ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9350938
• MDR Text Key: 184984791
• Report Number: 1818910-2019-116465
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER GLENOSPHERE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2019
• 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
• Patient Age: 79 YR