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

Catalog Number UNK SHOULDER IMPLANT

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Bone Fracture(s) (1870); Loss of Range of Motion (2032); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).

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.

Event Description

In the literature article entitled ¿revision of failed fracture hemiarthroplasties to reverse total shoulder prosthesis through the transhumeral approach¿ written by frank gohlke et al, published in the operative orthopadie und tramatologie no.2, 2007, was reviewed.This article discussed the objectives of a reverse shoulder replacement as well as the indications, contraindications, surgical technique, postoperative management and results.From 200-2005, a total of 84 shoulder replacement revisions were performed with the reverse prosthesis, of which 34 were revisions of failed fracture hemiarthroplasties through a bone window in the humerus.25 patients were followed prospectively for up to 59 months postoperatively; an additional nine patients were interviewed by telephone or in writing.Constant score improved from 17.5% preoperatively to 63% postoperatively.Range of motion was substantially improved, and pain was relieved in every patient.Function correlated to the extent of soft tissue damage.14 patients were very satisfied and four dissatisfied.There were eight complications in total.The article names two ¿trial implants¿ from depuy and a non-depuy prosthesis.It is unclear which implant was used to determine which implants had complications-if it was a depuy product or a non-depuy product.It also does not specify which implants the 34 patients had implanted prior to revision to a reverse shoulder prosthesis.Out of the 34 patients who were revised to a reverse shoulder implant; 14 had pre-existent insufficient rotator cuff and were managed with removal of hemiarthroplasties and revision to a the reverse prosthesis; in five cases, bipolar prosthesis were revised to a reverse shoulder prosthesis; seven patients had a reverse prosthesis implanted after removal of an infected hemiarthroplasty and conversion to an articulating spacer.The number of prior surgeries on average was 2.3 for fracture prosthesis.Preoperatively, 245 patients were suffering from a significant loss of the anterior part of the deltoid muscle and/ or partial denervation of the deltoid confirmed by emg because of previous interventions.In 28 patients, there was static anterosuperior migration of the humeral head or subluxation.Pseudoparalysis was diagnosed in all these patients because of rotator cuff insufficiency.In eight patients, intraoperative biopsies were positive without any apparent clinical signs of infections.Adverse events were identified on table 2 within the article and are as follows: dislocation of the epiphysis and glenoid ball (3 patients) which were revised in open technique, the height of the pe liner was increased and/or modular humeral lengthener added.The case of dissociation required revision with exchange of the stem and application of bone cement (manufacturer not specified) to prevent rotation and uncoupling.Periprosthetic fracture after adequate trauma (1 patient); this patient was unable to have the preoperative cement plug which extended to the supracondylar region of the distal humerus could not be removed at the first operation.The patient fell 11 months after surgery and sustained a periprosthetic fracture with temporary radial nerve paresthesia.At revision, a pre-contoured plate and fibular graft with cerclage were required.The cement from the primary operation was completely removed and replaced by cancellous bone graft.Heterotopic ossification (1 patient) which required removal of the ossification and protruding cerclage wire to alleviate painful impingement.Postoperative radial nerve paresthesia with complete regeneration (1 patient) recurrent prosthesis infection, low grade (1 patient) which required a two stage revision with articulating spacer prosthesis and addition of vancomycin and gentamicin was necessary.Disconnection of the humeral epiphysis and the diaphyseal shaft (1 patient) at the time of final follow-up.88% of patients were satisfied with surgical outcome.There was distinct pain reduction in all cases and improvement in the active range of motion in 30 cases, restoring adl performance.All patients would agree to have the operation again.Due to loss of the external rotators, twelve of the 25 patients manifested a significant limitation in external rotation in 90-degree abduction.The postoperative outcome declined in relation to the number of previous operations, the lack and/or insufficiency of the rotator cuff with fatty atrophy, and complete loss of the tuberosities (17 patients).At the final follow-up, radiologic analysis did not reveal any loose implants.Inferior notching was seen in four patients.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional 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.Device history lot: null.Device history batch:null.Device history review: null.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
• MDR Report Key: 9460969
• MDR Text Key: 185413496
• Report Number: 1818910-2019-121193
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER IMPLANT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention