MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US REPLICA SM STAT SHT RT 12.0MM; REPLICA IMPLANTS : HIP FEMORAL STEM

Catalog Number 153017000

Device Problem Biocompatibility (2886)

Patient Problems Pain (1994); Tissue Damage (2104); Test Result (2695); No Code Available (3191)

Event Date 01/31/2014

Event Type  Injury  

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.Occupation: attorney.(b)(4).

Event Description

Litigation papers allege the patient suffered from pain, metallosis, fluid build-up, mental anguish and a limp.Update rec'd 1/14/2014: pfs and medical records received.A correct doi was given for the right implant.After review of the left revision operative note it confirmed metallosis.Update rec'd 8/25/2014: pfs and medical records received.A dor was provided for the right hip.The revision operative note for the left hip stated the metallosis was between the head and trunnion, not the head and liner.The left side stem is being added.The right side revision note also indicated metallosis, but between the liner and head.Update ad 31 jul 2018: (b)(4) been re-opened under (b)(4) due to the receipt of ppf and sticker sheets.In addition to what were previously alleged, ppf alleges metal wear, metallosis, and elevated metal ions.

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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: REPLICA SM STAT SHT RT 12.0MM
• Type of Device: REPLICA IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8603106
• MDR Text Key: 144803606
• Report Number: 1818910-2019-93216
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K934334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/18/2019

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 Catalogue Number: 153017000
• Device Lot Number: W5TC41004
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/18/2019
• Initial Date FDA Received: 05/13/2019
• Supplement Dates Manufacturer Received: 09/03/2021
• Supplement Dates FDA Received: 09/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 98