MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM 28MM +0 M HEAD; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number	1365-16-500
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Joint Dislocation (2374); No Code Available (3191)
Date of Event	05/29/2008
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Occupation: lawyer.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
Pinnacle claim form and medical records received.After review of medical records, it was stated that the patient was revised to address instability and recurrent dislocations.The patient was reported to have slipped and fell on (b)(6) 2007 resulting to pain and dislocation.Several incidents of dislocations were reported and were treated with closed reduction.There was also a noted broken screw in the previous reduction; however, it is unknown which specific screw broke.Revision surgery was then opted on (b)(6) 2008.Revision notes reported abundant scar and there was soft tissue laxity and valgus instability.Moreover, during the initial hip replacement on (b)(6) 2007, the srom stem and sleeve were too tight in the bone so the srom stem backed out and femur over reamed to 12mm.A cable was used to avoid insertional fracture.In this course, it resulted to posterior avulsion of the greater trochanter.Later on (b)(6) 2007, an i&d and evacuation of hematoma was done and the avulsion was repaired.Doi: (b)(6) 2007; dor: (b)(6) 2008; right hip.
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.No device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.  the reported event is considered one of the possible complications of joint replacement.Investigational inputs were requested as indicated per internal procedures for this failure mode.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 wi-7915 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 product contribution to the reported event was identified and no information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot - null.Device history batch - null.Device history review - null.

• Brand Name: SROM 28MM +0 M HEAD
• Common Device Name: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9699613
• Report Number: 1818910-2020-04577
• Device Sequence Number: 11478265
• Product Code: JDI
• UDI-Device Identifier: 10603295033141
• UDI-Public: 10603295033141
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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 Expiration Date: 05/31/2012
• Device Model Number: 1365-16-500
• Device Catalogue Number: 136516500
• Device Lot Number: 2377914
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/26/2020
• 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: 51 YR