MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 DELTA CER HEAD 11/13 32MM +6; S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS

Catalog Number	136532230
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint : (b)(4).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
Ppf alleges dislocation with closed reduction after first revision.
Additional Manufacturer Narrative
(b)(4).No device associated with this report was received for examination.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: DELTA CER HEAD 11/13 32MM +6
• Common Device Name: S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8253190
• Report Number: 1818910-2019-81108
• Device Sequence Number: 2154032
• Product Code: LZO
• UDI-Device Identifier: 10603295033424
• UDI-Public: 10603295033424
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K031803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2018

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 Expiration Date: 10/31/2020
• Device Catalogue Number: 136532230
• Device Lot Number: 8217362
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/23/2018
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 01/25/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention