MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 11/13 S-ROM 40MM M SPEC+0; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number	1365-42-500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	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)
Date of Event	10/03/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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.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.
Additional 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.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.
Event or Problem 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.
Additional 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.Additional narrative: udi: (b)(4).H6 patient code: no code available (3191) used to capture the device revision or replacement.
Event or Problem 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.
Additional 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).

• Brand Name: 11/13 S-ROM 40MM M SPEC+0
• Common Device Name: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9246471
• Report Number: 1818910-2019-112590
• Device Sequence Number: 2486072
• Product Code: JDI
• UDI-Device Identifier: 10603295033752
• UDI-Public: 10603295033752
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K060031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2011
• Device Model Number: 1365-42-500
• Device Catalogue Number: 136542500
• Device Lot Number: 2248043
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 11/18/2019; 03/16/2020; 04/23/2020; 04/30/2020
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 11/20/2019; 04/06/2020; 04/28/2020; 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR