MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,30+4L NK,14X09X130; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number	563514
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Discomfort (2330); Hypoesthesia (2352); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
Date of Event	10/14/2013
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
Complaint description: litigation alleges the patient suffers from pain, discomfort, inflammation, numbness, limited mobility and difficulty bearing weight.After review of the medical records the revision operative note revealed the cup was anteverted too much and was replaced.The cup is being reported for malpositioning.In addition to what were previously alleged, ppf alleges elevated metal ions, metal wear and metallosis.Doi: (b)(6) 2007 - dor: (b)(6) 2013 (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.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 (b)(4) 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 information received with this individual complaint indicated that a broader investigation or corrective action was 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 HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8971369
• Report Number: 1818910-2019-103376
• Device Sequence Number: 18890545
• Product Code: JDI
• UDI-Device Identifier: 10603295178187
• UDI-Public: 10603295178187
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2014

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: 12/31/2011
• Device Catalogue Number: 563514
• Device Lot Number: 2282855
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 11/19/2019
• 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: 45 YR
• Patient Weight: 63