MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT CEMENTED STEM SZ3 STD; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-03-090
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Tissue Damage (2104); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	01/17/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Complaint description: pfs and medical records received.After review of the medical records for mdr reportability, the patient was revised for dislocation and instability.Update 17 aug 2018 com-(b)(4) has been re-opened under pc-(b)(4) due to receipt of ppf, implant records and sticker sheets.In addition to what were previously alleged, ppf alleges pseudotumor, constrained liner, bone fracture, abductor muscle repair, infection, and loosening of stem.Doi: (b)(6) 2013 (liner and head) - dor: (b)(6) 2014 (right hip).Doi: (b)(6) 2004 (cement, screws, cement restrictor, stem centralizer, apex hole eliminator, stem, and cup).
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.
Event or Problem Description
After review of medical records, it was found that no infection occurred during this revision.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: investigative update: 30 / august / 2021.Additional patient x-ray images have been provided for review.No device associated with this report was received for examination.Provided images are paper copies within patient medical records.One image is of very poor quality.The patient is noted to have had bi-lateral hip replacement.This report involves the right hip.It was not possible to confirm the reported stem loosening.Nothing indicative of a product problem is identified.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 material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SUMMIT CEMENTED STEM SZ3 STD
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9321135
• Report Number: 1818910-2019-116090
• Device Sequence Number: 18918724
• Product Code: JDI
• UDI-Device Identifier: 10603295059530
• UDI-Public: 10603295059530
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K013352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2015

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1570-03-090
• Device Catalogue Number: 157003090
• Device Lot Number: YX5DL1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 11/08/2019; 09/16/2021
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 11/29/2019; 09/20/2021
• 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: 73 YR
• Patient Weight: 61