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

Model Number 56-3618

Device Problems Use of Device Problem (1670); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Host-Tissue Reaction (1297); Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Nausea (1970); Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 10/03/2019

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

It was reported that the patient had stiffness, and fullness in the left hip region as well as a small pseudotumor.The 40mm metal on metal liner and 40mm head along with the stem were removed and replaced with 36/60 neutral liner and a new stem and 36mm delta 11/13 srom head was implanted.The patient requested all removed implants to be returned to him.Doi: (b)(6) 2008; 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.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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).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 caused or contributed to the potential event described in this report.Udi: (b)(4).Patient code: no code available ((b)(4)) used to capture the device revision or replacement.

Event Description

Pcf and medical records received.After review of medical records, patient was revised to address left hip failed total hip arthroplasty.Patient alleges pain, stiffness, and limitation of function.Mri scans have shown in a serial sense a growing area of soft tissue change around his hip consistent with potential mild pseudotumor.Revision notes stated of adverse soft tissue reaction through the region of the pseudocapsule.The anteversion of the femoral neck was slightly high at about 45-50 degrees and there was a little bit of nausea at the back of the neck.The trunnion was in pretty bad shape with difficulty from what appeared to be trunnionosis.

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: corrected: h6 (the previous patient code nausea is being retracted as per additional information received).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, a follow-up medwatch will be filed as appropriate.

Event Description

Upon pic supplemental preparation, further review of note a-3831530 and consultation with reviewer of the note resulted in findings that "nausea" does not correspond to patient's experience but was noted in intra-operative findings associated with the stem where stated "there was a little bit of nausea in the back portion of the femoral neck" (page 47 of (b)(4) pcf_medical records ad 04 feb 2020).All subjective reports of patient experience indicate "nausea none" throughout the medical record.The code nausea refers to gastrointestinal condition that would be subjectively reported by patient not as an intra-operative finding.

• 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: 9246472
• MDR Text Key: 174606740
• Report Number: 1818910-2019-112588
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295178224
• UDI-Public: 10603295178224
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/03/2019

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: 03/31/2013
• Device Model Number: 56-3618
• Device Catalogue Number: 563618
• Device Lot Number: 2587841
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 10/28/2019
• Supplement Dates Manufacturer Received: 11/18/2019; 03/16/2020; 04/28/2020; 05/12/2020
• Supplement Dates FDA Received: 11/20/2019; 04/06/2020; 05/11/2020; 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR