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 Pain (1994); Injury (2348); Osteolysis (2377); No Code Available (3191)

Event Date 01/01/2013

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.(b)(4).

Event Description

The literature article entitled ¿resurfacing humeral prosthesis: do we really reconstruct the anatomy?¿ by pierre mansat, md, phd; anne-sophie coutie, md; nicolas bonnevialle, md; michel rongieres, md, michel mansat, md; and paul bonnevialle, md; published in the journal of shoulder and elbow surgery, 2013, 22, 612-619, was reviewed.The article¿s purpose was to report on a study that investigated the hypothesis that the resurfacing humeral prosthesis restores the normal glenohumeral relationships and correlates with the final clinical results.The article reports the global c.A.P.Resurfacing implant was used (depuy).There were five different sized humeral heads used.There were 61 patients, 64 shoulders that were monitored during the study.All patients were monitored prospectively, clinically and radiographically, at 3 and 6 months, 1 and 2 years, and at the last follow-up.Clinical evaluation along with radiographic analysis was performed.Average follow-up was 36 months.Only one shoulder had visible lucent line, which osteolysis was seen around the central peg, without sign of evolution with follow-up.There was no sign of migration of the resurfacing implant.No infection occurred in the series as well as no humeral head fractures observed during impaction of the resurfacing implant.At follow-up, pain was still moderate or severe in 11 shoulders.Glenoid erosion was noted in all shoulders, with not joint line visible on radiographic analysis.One shoulder was diagnosed with a re-rupture of the supraspinatus tendon.A revision surgery was performed in five shoulders after a bone scan showed a specific hyper fixation on the glenoid side without another location of hyper fixation.A glenoid resurfacing with a cemented glenoid implant was performed in 2 patients at 24 months and 36 months after the initial procedure, while keeping the resurfacing humeral prosthesis.There was a revision to a reverse total shoulder prosthesis in two patients at 30 months and 60 months after the initial procedure.Glenoid wear was associated in these two shoulders with poor rotator cuff function.There was also another revision to a pyrocarbon ¿snooker ball¿ without glenoid resurfacing, at 60 months after the initial procedure.There were 5 different sized humeral heads used: 40mm, 44mm, 48mm, 52mm and 56mm.

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.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 complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction (b)(4) appendix a.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 indicates that a broader investigation or corrective action was necessary.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.Post market surveillance is per (b)(4).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): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9294027
• MDR Text Key: 184901143
• Report Number: 1818910-2019-114978
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• 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: 11/07/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2019
• 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