MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT POR TAPER SZ3 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number 157001090

Device Problems Corroded (1131); Degraded (1153); Disconnection (1171); Loose or Intermittent Connection (1371); Inadequacy of Device Shape and/or Size (1583); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body Reaction (1868); Bone Fracture(s) (1870); Pain (1994); Injury (2348); Osteolysis (2377); Ambulation Difficulties (2544); Test Result (2695); No Code Available (3191)

Event Date 07/02/2018

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.(b)(4).

Event Description

Asr litigation record received.Litigation alleges cup produced metallic debris, cup detachment, disconnection, loosened acetabulum, pain, abnormal blood metal ions, inhibited ability to walk, and injury.

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.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.Additional narrative: added description of event or problem and evaluation codes (patient, device code).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

After review of medical records, it was indicated that during the primary surgery, the size 3 summit stem was found to be 1-2 mm more proud than the broach.When the stem inserter was removed, it was quite tight within the femoral stem and as this was being wiggled back and forth to be removed, a small longitudinal unicortical fracture of the greater trochanter occurred.

Manufacturer Narrative

Product complaint #
=
> (b)(4).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.Added (patient and device codes).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pfs and medical records received.After review of medical records, the patient was revised to address a large posterior pseudotumor, elevated serum cobalt and chromium levels and pain.Intra-operative findings include a large, thick posterior pseudocapsule filled with gray-brown fluid, degenerated gluteus medius tendon, gray-stained and thickened capsular tissue, osteolysis around the acetabular and femoral component and a mild amount of corrosion on the femoral trunnion.

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.Per internal procedures, the event information was reviewed.No investigational inputs were received.For this investigation, no immediate action was required as no alleged deficiency with the device(s) was identified.No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Investigational inputs were requested as indicated per internal procedures for this failure mode, however no information was provided to depuy without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No product contribution to the reported event was identified.No evidence was found indicating product error was a contributing factor.The need for corrective action was not indicated.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.H10 additional narrative: added: d4 (lot), h6 (patient).Corrected: h6 (device).Patient code: no code available (3191) is used to capture tendon injury and surgical intervention.

• Brand Name: SUMMIT POR TAPER SZ3 STD OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8013824
• MDR Text Key: 125289613
• Report Number: 1818910-2018-73718
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/01/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 157001090
• Device Lot Number: B61DW1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2018
• Initial Date FDA Received: 10/29/2018
• Supplement Dates Manufacturer Received: 11/14/2018; 06/24/2019; 12/05/2019; 10/29/2020
• Supplement Dates FDA Received: 11/15/2018; 06/26/2019; 12/05/2019; 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR