MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC 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 Cyst(s) (1800); Edema (1820); Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Pain (1994); Weakness (2145); Anxiety (2328); Distress (2329); Discomfort (2330); Injury (2348); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Not Applicable (3189); No Code Available (3191)

Event Date 06/21/2018

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.

Event Description

Asr litigation received.Litigation alleged injury, pain, stiffness, discomfort, weakness which negatively affected plaintiff's mobility, anxiety, emotional distress and metal toxicity in the body.Doi: (b)(6) 2008; dor: (b)(6) 2018; left hip.

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

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.

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.H10 additional narrative: h6 patient code: no code available (3191) was used to capture emotional distress, bone injury, limb asymmetry and surgical intervention.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.

Event Description

Revision notes stated that there was a large cyst-like structure extending posteriorly behind the acetabulum and drained out 100ml of bloody fluid.There was significant amount of pseudotumor.Head was removed.Cup was removed with minimal bone loss.There was an increased leg lengths slightly from preoperative levels.Leg lengths appeared to have been increased by about 3mm to 4mm.

• Brand Name: SROM STM STD 36+12L 17X22
• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7889328
• MDR Text Key: 120727287
• Report Number: 1818910-2018-69760
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/24/2018

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: 10/31/2013
• Device Catalogue Number: 563622
• Device Lot Number: 2749705
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 10/02/2018; 02/03/2019; 06/05/2020
• Supplement Dates FDA Received: 10/03/2018; 02/13/2019; 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVE 11/13 +6; ASR ACETABULAR CUPS 60; ASR UNI FEMORAL IMPL SIZE 53; S-ROM*SLEEVE PRX ZTT, 22B-LRG
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR