MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SROM STM STD 36+12L 17X22; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number 563622

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Tissue Damage (2104); Distress (2329); Injury (2348); Ambulation Difficulties (2544); Test Result (2695); No Code Available (3191)

Event Date 11/20/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Representing surgical intervention.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pending metal on metal hip product liability, customer alleges damages from device.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: 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.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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).

Event Description

Medical records received.After review of medical records, the patient had undergone a right hip resection surgery possibly due to either infection or metallosis.There appeared to be some rent in the gluteus maximus fascia and gluteus maximus proximally which made these difficult to identify.The femoral cup was noted to be loose.A gray, cheesy-appearing pseudocapsule, which was consistent with metallosis was removed.Surgeon notes that there was marked dead bone about the cup.There was also some heterotrophic bone.Patient had all implants removed and replaced with antibiotic cement.It is unknown if the cement used was depuy.Additionally, during the index operation, the patient had lost approximately 1400 cc of blood due to the bleeding from the bone and the acetabulum after machining and cutting bone.Patient received 2700 cc of crystalloid fluids.Doi: (b)(6) 2006 - dor: (b)(6) 2017 (right hip).

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.H10 additional narrative: added a2, b5, b7, d4 (expiration date) and h6 (patient codes).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H6 patient code: no code available (3191) used to capture the patient code medical device removal.

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.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

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.No code available (3191) is used to capture emotional distress and to replace surgical intervention with device revision or replacement.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SROM STM STD 36+12L 17X22
• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7918415
• MDR Text Key: 181425987
• Report Number: 1818910-2018-70793
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K851422
• 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: 09/03/2018

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: 06/30/2009
• Device Catalogue Number: 563622
• Device Lot Number: 1215131
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 09/28/2018
• Supplement Dates Manufacturer Received: 10/05/2018; 04/30/2019; 10/10/2019; 02/18/2020; 11/03/2020; 06/29/2021
• Supplement Dates FDA Received: 10/08/2018; 05/03/2019; 10/25/2019; 02/28/2020; 11/17/2020; 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVE 11/13 +0; ASR ACETABULAR CUPS 54; ASR UNI FEMORAL IMPL SIZE 47; S-ROM*SLEEVE PRX ZTT, 22D-SML
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 85