MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICUL/EZE BALL 32 +1 GR; FEMORAL HEADS

Model Number	1554-02-150
Medical Device Problem Codes	Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	01/06/2010
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.(b)(4).Occupation: attorney.
Event or Problem Description
Litigation papers allege the patient suffers from pain and discomfort.Update ad 31 jul 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf, sticker sheets and implant records.In addition to what were previously alleged, ppf alleges loosening of cup and stem.
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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. udi:(b)(4).
Event or Problem Description
Pfs alleges walking difficulty, fracture (bone) and limited range of motion.After review of medical records, patient was revised to address loose painful left hip replacement.Added weight, height and updated patient harms.Doi: (b)(6) 2006.Dor: (b)(6) 2010.Left hip.Patient is bilateral please see (b)(4).For the right hip.

• Brand Name: ARTICUL/EZE BALL 32 +1 GR
• Common Device Name: FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8421082
• Report Number: 1818910-2019-84822
• Device Sequence Number: 2205892
• Product Code: JDI
• UDI-Device Identifier: 10603295058373
• UDI-Public: 10603295058373
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• PMA/510(K) Number: K843909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2019

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: 10/31/2011
• Device Model Number: 1554-02-150
• Device Catalogue Number: 136521000
• Device Lot Number: 2251816
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 03/11/2019; 02/17/2020
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 03/20/2019; 02/19/2020
• 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: 61 YR
• Patient Weight: 91