MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM STM STD 36+12L 13X18; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number 563618

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

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Weakness (2145); Anxiety (2328); Distress (2329); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 06/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.(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 alleging injury, economic loss, elevated cobalt and chromium metal ion levels, pain, stiffness, discomfort, weakness which negatively affected the plaintiff's mobility, limitations in the ability to perform normal physical abilities, anxiety, metal toxicity, suffering and emotional distress.Doi: (b)(6) 2009; dor: (b)(6) 2019 (left 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.  h6 patient code: no code available (3191) is used to capture blood heavy metal increased and 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

After review of the medical records the patient was revised to address metallosis, pain, function limitation secondary to adverse local tissue reaction.Operative note reported a large fluid-filled pseudotumor with a metal stained tissue on deep dissection of the posterior capsule and capsular debridement was performed.Doi: (b)(6) 2009: dor: (b)(6) 2019; left hip.

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 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.

• Brand Name: SROM STM STD 36+12L 13X18
• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9575100
• MDR Text Key: 185737127
• Report Number: 1818910-2020-01440
• 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
• Report Date: 05/19/2020

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: 563618
• Device Lot Number: 2869196
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 02/04/2020; 05/19/2020
• Supplement Dates FDA Received: 02/10/2020; 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASR ACETABULAR CUPS 62; ASR TAP SLV ADAP 11/13 -3; ASR UNI FEMORAL IMPL SIZE 55; S-ROM*SLEEVE PRX ZTT, 18D-SML
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 90