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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER HUMERAL HEADS
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DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER HUMERAL HEADS Back to Search Results
Catalog Number UNK SHOULDER HUMERAL HEAD
Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Patient Problems Pain (1994); Joint Dislocation (2374)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Initial reporter: patient.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Patient communication received.It was reported that the patient was operated approximately 4 and a half years ago (b)(6) 2014) on the left shoulder.The implants were gleno epoca 5213-50 monoblock glenoid implant, standard humeral head tete epoca 5555-50/20 and articular ligament.The patient had recurrent dislocation and pain.His shoulder creaks and squeaks during movements and shows that the prosthesis was worn.Doi: (b)(6) 2014, dor: none reported, (left shoulder).
 
Manufacturer Narrative
Product complaint # (b)(4).¿this product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.¿.
 
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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 Key8635942
MDR Text Key145928216
Report Number1818910-2019-94391
Device Sequence Number1
Product Code HSD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 05/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK SHOULDER HUMERAL HEAD
Was Device Available for Evaluation? No
Date Manufacturer Received06/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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