MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SROM STM ST,36+6L NK,11X16X150; FEMORAL STEM

Catalog Number 563517

Device Problems Off-Label Use (1494); Positioning Problem (3009); Migration (4003)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 07/18/2008

Event Type  Injury  

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.Device was used for treatment, not diagnosis.Initial reporter occupation: non-healthcare professional: "attorney".(b)(4).

Event Description

Pfs and medical records received.Pfs has no allegation.After review of medical records, patient was revised to address unstable hip and polyethylene wear.Revision notes reported of fluid and extremely scarred in the hip.It looked like the z-cone has subsided but no signs of loosening.Doi: (b)(6) 2006; dor: (b)(6) 2008; (right hip).

Event Description

After review of medical records, patient was revised to address pain, adhesive capsulitis and poly wear.It was also stated that that the anerversion of the stem was changed to slightly anteverting.There is no signs of loosening but it looked like the z-cone had subsided.The poly appeared to be wear.Patient had dislocated out the front the first time slightly over retroverted her and so decided to dislodge the srom stem and then re-impacted it in about probably 5 to 10 degrees of more anteversion.Updated product codes and lot numbers.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.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.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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).

• Brand Name: SROM STM ST,36+6L NK,11X16X150
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8505443
• MDR Text Key: 141645834
• Report Number: 1818910-2019-90462
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295178200
• UDI-Public: 10603295178200
• Combination Product (y/n): N
• PMA/PMN Number: K954935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2010
• Device Catalogue Number: 563517
• Device Lot Number: 1978579
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/11/2019
• Supplement Dates Manufacturer Received: 03/19/2019; 08/07/2019
• Supplement Dates FDA Received: 04/17/2019; 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 77