MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM STM ST,36+6L NK,11X16X150; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number 56-3517

Device Problems Fracture (1260); Osseointegration Problem (3003)

Patient Problems Inflammation (1932); Pain (1994); Swelling (2091); Discomfort (2330); Depression (2361); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); Not Applicable (3189); No Code Available (3191)

Event Date 09/08/2014

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.

Event Description

Litigation alleges the patient suffers from pain, discomfort, inflammation, a popping/snapping sensation, and large amounts of toxic cobalt-chromium metal ions and particles to be released into the blood, tissue and bone.Update: 12/12/2014- pfs and medical records received.After review of the medical records for mdr reportability, the patient's most recent lab results from (b)(6) 2014 indicated the cobalt level was 0.6 abd chromium level was <0.2.The stem isn't being reported at this time for the high metel ions.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: 1/6/2015.Additional information: doi: (b)(6) 2005; dor: none reported; (left hip).Patient is a resident of (b)(6).During the primary operation ((b)(6) 2005) a retained drill bit was removed from a previous operation.The manufacturer of the drill bit is unknown at this time.Pfs/medical records attached / (b)(6), 1/6/2015.16jan2015 updated patient harms and/or product codes.(b)(4).Update ad 28 aug 2018: (b)(4) was re-opened due to receipt of der.It was reported that the distal portion of the srom stem was broken.Stem was well fixed.The distal spline of the stem was removed easily after the stem was removed.Stem has been broken since 2015.Liner exchange (ultamet) was also performed.Pinnacle shell (121720046/(b)(4)) and srom sleeve (550514/(b)(4)) remain insitu.Patient requested that the components be saved for her attorney.Doi: (b)(6) 2005; dor: (b)(6) 2018; left hip.

Manufacturer Narrative

Udi: (b)(4).

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.  additional narrative:  udi: (b)(4).

Event Description

Pfs alleges swelling, difficulty walking and depression.

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.

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.H6 patient code: no code available (3191) used to capture the surgical intervention.

• Brand Name: SROM STM ST,36+6L NK,11X16X150
• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7897714
• MDR Text Key: 121012814
• Report Number: 1818910-2018-70049
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295178200
• UDI-Public: 10603295178200
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/28/2018

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: 03/31/2010
• Device Model Number: 56-3517
• Device Catalogue Number: 563517
• Device Lot Number: 1881118
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 09/21/2018
• Supplement Dates Manufacturer Received: 12/05/2018; 03/12/2019; 03/12/2019; 10/29/2020
• Supplement Dates FDA Received: 12/07/2018; 03/22/2019; 04/03/2019; 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 97