MAUDE Adverse Event Report: DEPUY FRANCE SAS ¿ 3003895575 LATERALIZD HUM CUP DIA 36+6MM; SHOULDER BEARING

Catalog Number	4CHL636
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Code Available (3191)
Date of Event	10/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The patient was revised to address dislocation at right reverse total shoulder and poly wear with soft tissue imbalance.Original surgery approx 15 years ago.
Additional Manufacturer Narrative
No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible for the unknown lot code(s).Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will 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: LATERALIZD HUM CUP DIA 36+6MM
• Common Device Name: SHOULDER BEARING
• Manufacturer (Section D): DEPUY FRANCE SAS ¿ 3003895575 ; 7 allée irène joliot curie; bp 256; saint priest cedex, rhone alpes 69801 ; FR 69801
• MDR Report Key: 7022754
• Report Number: 1818910-2017-28737
• Device Sequence Number: 19128731
• Product Code: KWS
• UDI-Device Identifier: 10603295170471
• UDI-Public: 10603295170471
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K021478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 4CHL636
• Device Lot Number: 1848150
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 58