MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 SUMMIT POR TAPER SZ7 HI OFF; HIP FEM STEM/SLEEVE

Catalog Number 157011135

Device Problems Corroded (1131); No Apparent Adverse Event (3189)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Discomfort (2330); Ambulation Difficulties (2544); No Code Available (3191); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2013

Event Type  Injury  

Event Description

Patient was revised to address high metal level.Update: (b)(4) 2013 - litigation papers received.Litigation alleges pain, discomfort, difficulty ambulating, tissue damage and fluid collections.There is no additional information that would affect the outcome of this investigation.Update has been electronically attached to the complaint document.Update rec'd (b)(4) 2014 - pfs and medical records received.Revision operative notes indicate metallosis, a pseudocapsule, and corrosion.The stem has now been reported.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: (b)(4) 2014.

Manufacturer Narrative

Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The investigation is ongoing.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

The devices associated with this report were not returned.Medical records were obtained and reviewed by a medical professional.From a medical perspective, based on the information available, the complaint is unlikely to be product related.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Ppf and sticker sheets received.Ppf alleges elevated metal ions confirmed in medical records.

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 Description

Ppf and sticker sheet received.Pinnacle plaintiff profile form alleges elevated metal ions.Doi: (b)(6) 2008; dor: (b)(6) 2013; right hip.

Manufacturer Narrative

(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.

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.  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.

Manufacturer Narrative

Product complaint # (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

Manufacturer Narrative

Product complaint # (b)(4).This follow-up was pass/complete by it support due to defect so it should be able to be submitted once the information is repopulated on a new mw on the correct ra.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.H10 additional 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.Recaptured codes in h6.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT POR TAPER SZ7 HI OFF
• Type of Device: HIP FEM STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 3600313
• MDR Text Key: 16686664
• Report Number: 1818910-2014-11857
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/07/2014

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
• Device Operator: Health Professional
• Device Catalogue Number: 157011135
• Device Lot Number: B88DF1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2014
• Initial Date FDA Received: 01/30/2014
• Supplement Dates Manufacturer Received: Not provided; 05/15/2018; 05/15/2018; 08/30/2018; 08/30/2018; 07/17/2023
• Supplement Dates FDA Received: 12/15/2014; 06/13/2018; 06/14/2018; 09/26/2018; 07/31/2023; 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 88 KG