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 Ossification (1428); Thrombosis (2100)

Event Date 01/01/2011

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 literature article entitled ¿shoulder heterotopic ossification after bilateral hemiarthroplasty: case report and review of the literature¿, by jonathon cheah, bs; phillip nigro, md; eric smith, md; and elizabeth matzkin, md; published in the journal of shoulder and elbow surgery, 2011, 20, e7-e13, was reviewed.This was a case report to document the unique complication of bilateral ho after bilateral shoulder hemiarthroplasty and discuss its impact on the patient¿s range of motion in relation to the previous literature.This report presents a (b)(6) year old left hand dominant male with bilateral comminuted proximal humeral fracture dislocations sustained after an unwitnessed fall.The patient¿s history was notable for two posterior fossa epidermoids that required neurosurgical craniectomy for resection 12 and two years prior.Other medical comorbidities included atrial fibrillation, diabetes, hypertension, hyperlipidemia, hemicolectomy after colon cancer, benign prostatic hypertrophy, prior cerebrovascular accident, grave disease, chronic obstructive pulmonary disease, and prior inferior myocardial infarction.After the patient was medically stabilized, he underwent left shoulder hemiarthroplasty on day eight and right shoulder hemiarthroplasty on day 12.The two procedures were performed by different surgeons, but with similar techniques and instrumentations.Fracture hematoma was encountered and cleaned with irrigation.Both humeral heads were identified as being fractured with posterior displacement and angulation.The greater and lesser tuberosities of both shoulders were fractured, but with intact attachments to the rotator cuff tendons.The left shoulder was replaced by cementing a 12mm global fx (depuy) stem with a 52- x18 mm humeral head into the humeral shaft.The right shoulder underwent similar repair with a 12 mm global fx (depuy) stem and a 48- x18 mm humeral head.Medium viscosity bone cement with gentamicin was used for both implants.A bone graft from the humeral head was used to fill defects in the tuberosities.Both shoulders showed correct placement and demonstrated good range of motion and stability.Each procedure was performed under general anesthesia and the patient was extubated without any complication or prolonged use of neuromuscular blockades.Each shoulder procedure had an estimated blood loss of 400 ml.During the second shoulder procedure, the patient received one unit of packed red blood cells intraoperatively, and one more unit on the postoperative day one for a hematocrit of 30.On postoperative day four, he was given another two units of packed red blood cells because his hematocrit had drifted down to 24.Thereafter, the patient¿s hematocrit remained stable at 30, and he showed no clinical signs of bleeding.After the last shoulder procedure, the patient was placed on enoxaparin bridge and started on warfarin for a lower extremity dvt.At 3.5 months, the patient experienced significant pain during physical therapy to gain range of motion in his shoulders.Physical examination showed that range of motion was limited and radiographs showed bilateral grade iv ho that bridged across the glenohumeral joints and had progressed in severity by the six month postoperative visit in both externally and internally rotated anteroposterior views.Axillary views could not be obtained due to the patient experiencing pain secondary to the restricted range of motion.Increased lucency around the lateral stem of each prosthetic implant was noted.However, given the patient¿s pain relief and progressive glenohumeral ossification, these lucencies were unlikely to have contributed to this patient¿s postoperative complaints of restricted range of motion.By the six-month postoperative visit, the patient¿s range of motion had become progressively more limited.The patient has expressed interest in resection of the ho in his left dominant shoulder, however this treatment will be considered at the one-year postoperative interval to allow maturation of ho.The unusual severity of the patient¿s ho may suggest other potential contributors, because he does not have typical risk factors.There are limited number of studies about ho and neurologic injury.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #
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> (b)(4).Investigation summary
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> no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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
• MDR Report Key: 9378609
• MDR Text Key: 185075439
• Report Number: 1818910-2019-118183
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• 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
• Date Manufacturer Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention