MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*HEAD FEMRL ALUMINA 32+0; S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS

Catalog Number	528323
Medical Device Problem Codes	Fracture (1260); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)
Date of Event	12/28/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Der states that on (b)(6) 2017 patient reports no fall but is unable to use her left hip.Present to the er and it was radiographically discovered that the patient ceramic head had fractured.A disturbing situation discovered while they was trying to book the necessary revision component to help fix the ladies hip were the unavailability of a duraloc poly option thus requiring the surgeon to remove a well fix duraloc cup.Along with a catastrophic failure of the ceramic components the surgeon has reported this to the fda.Patient was taken to the operating room (or) on (b)(6) 2017 and all components except for the metaphyseal sleeve removed.There was extreme difficulty in removing the ceramic liner from the duraloc cup.They are unsure if the failure to the liner was caused prior or after the failure of the head.The duraloc cup wa removed with the zimmer cup out and the patient was revised using primary implants.The surgeon chose a metal head and a poly liner.He was also given an option of another more current ceramic on ceramic option but decided against it.They tried to find why the poly was not available, they spoke with the area vice president.He was able to find out that the poly option for the duraloc cup was in transition period created by the fda and depuy.Doi: (b)(6) 2008, dor: (b)(6) 2017, left hip.Surgical delay of 1 hour.
Event or Problem Description
Update jan 10, 2018: after review of the medical records: the patient underwent primary surgery on her left hip on (b)(6) 2008.Primary surgery notes were included in the medical records.Revision is stated to be on (b)(6) 2017¿revision notes are not included in the available medical records at the time of this review.A preoperative note from (b)(6) 2017 was included and stated revision surgery was needed due to pain, audible squeaking of the hip, and an implant fracture of the head.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.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.

• Common Device Name: S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7211791
• Report Number: 1818910-2018-51731
• Device Sequence Number: 10980055
• Product Code: JDI
• UDI-Device Identifier: 10603295171478
• UDI-Public: 10603295171478
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K913231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/28/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 528323
• Device Lot Number: 2701354
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2017
• Supplement Date Received by Manufacturer: 01/10/2018; 11/21/2018
• Initial Report FDA Received Date: 01/23/2018
• Supplement Report FDA Received Date: 01/31/2018; 11/22/2018
• 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 Age: 62 YR