MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SROM*STM ST,36+8L NK,18X13X160; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number 52-3418

Device Problems Metal Shedding Debris (1804); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Tissue Damage (2104); Weakness (2145); Discomfort (2330); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Not Applicable (3189); No Code Available (3191)

Event Date 05/11/2015

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pinnacle ppf and sticker sheets received.Ppf alleges pseudotumor, metal wear, metallosis and elevated metal ions.It is also being indicated that the cup, liner, head and stem were removed.Doi: (b)(6) 2008; dor: (b)(6) 2015; right hip.

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) 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.Device history lot 2654707.Device history review: 12 parts were manufactured as per specification and all raw materials met specification.There were no ncs or deviations associated with this lot.If information is obtained that was not available for the initial medwatch , a follow-up medwatch will be filed as appropriate. .

Event Description

Pfs alleges pain, illness, weakness, limited mobility, fall, and discomfort.After review of medical records, the patient was revised failed right tha.Operative notes reported that there was significant metallosis.There were gross metal staining within the tissues of the capsule with a thickened rind and pseudotumor.There was a tremendous amount of osteolysis about the femur.The cup was 80 degrees abducted and 80 degrees anteverted.Additionally, there was a large amount of necrotic green bone.The patient was reported to have died on (b)(6) 2015; however, the medical records did not provide information if the cause of death was from depuy devices.

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.   additional narrative: no code available (3191) is used to capture (medical device removal).

Manufacturer Narrative

Product complaint # (b)(4).Following review of the patient's death certificate, this follow-up is being submitted to correct section b2 of follow-up 2.

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 : 2654707.Device history review : 12 parts were manufactured as per specification and all raw materials met specification.There were no ncs or deviations associated with this lot.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.

• 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: 7590621
• MDR Text Key: 110713206
• Report Number: 1818910-2018-61833
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295171034
• UDI-Public: 10603295171034
• 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: 12/11/2019

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 Model Number: 52-3418
• Device Catalogue Number: 523418
• Device Lot Number: 2654707
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 11/15/2018; 12/11/2019; 01/08/2020; 01/28/2020
• Supplement Dates FDA Received: 11/15/2018; 01/02/2020; 01/08/2020; 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 68