MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER IMPLANT

Catalog Number UNK SHOULDER

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

Patient Problems Hematoma (1884); No Code Available (3191)

Event Date 02/06/2013

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(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 literature article entitled ¿short and midterm results of reverse shoulder arthroplasty according to the preoperative etiology¿ by mathias wellmann; melena struck; marc frederic pastor; andre gettmann; henning windhagen; and tomas smith, published online in the arch orthopaedic trauma surgery on february 6, 2013 was reviewed.The purpose of the article was to review reverse shoulder arthroplasty to see if the preoperative etiology influences clinical results after rsa.The article reviewed 76 reverse shoulder arthroplasties for cuff tear arthropathy, fracture sequelae and revision arthroplasty.The follow-up consisted of 71 patients and the mean follow-up period was 23 months.All patients were evaluated postoperatively using the constant score and the simple shoulder test.The patients either had the delta extend (51) or the delta 3.2 (25), depuy, implanted.71 patients were clinically investigated for a follow-up examination.There were postoperative complications in 19 patients.Scapular notching was also noted in 33 patients." (b)(6) female; hematoma; aspiration of the hematoma.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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.Corrective action was not indicated.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 IMPLANT
• Type of Device: SHOULDER IMPLANT
• 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: 9320935
• MDR Text Key: 184988671
• Report Number: 1818910-2019-114662
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/18/2019

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 01/10/2020
• Supplement Dates FDA Received: 01/14/2020
• 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
• Patient Age: 74 YR