MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 18D-SML; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Model Number 55-0523

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

Patient Problems Emotional Changes (1831); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Anxiety (2328); Distress (2329); Discomfort (2330); Ambulation Difficulties (2544); Joint Laxity (4526); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 02/03/2015

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation papers allege pain, injury, and elevated metal ions.Update rec'd (b)(6) 2015 partial medical records received.Patient reported to have low metal ion levels of co 1 and cr 1.1.Patient was admitted for revision to address discomfort, osteolysis and disability.Complete revision procedure reports were not received.The information received does not change the mdr decision.This complaint was updated on (b)(6) 2015.Updated rec'd (b)(6) 2016 supplemental received.Part and lot information was provided.There is no new information that would change the existing mdr decision.Complaint was updated (b)(6) 2016 update ad (b)(6) 2019: (b)(4) has been re-opened under (b)(4) due to medical records and sticker sheets received.After review of medical records, the patient was revised due to painful tha of left hip, mechanical complication and metal debris induced synovitis, hip effusion and osteolysis of the femur.Operative note reported a large amount of brownish colored fluid, there is a mild amount of corrosion under the taper, fibrinous brown material in the joint with debris and brownish stained synovium, lysis in the greater trochanter and missing bone.Operative finding reported osteolysis in the femur and fluid pocket in the joint.Added expiration date , patient harm, pe code of cup and head, medical history and revision hospital.Added new ip stem due to a corrosion and osteolysis.Doi: (b)(6) 2006: dor: (b)(6) 2015; (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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15638791
• MDR Text Key: 302082983
• Report Number: 1818910-2022-20990
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295175285
• UDI-Public: 10603295175285
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

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: 55-0523
• Device Catalogue Number: 550523
• Device Lot Number: 1955380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/06/2022
• Initial Date FDA Received: 10/20/2022
• Supplement Dates Manufacturer Received: 12/26/2022
• Supplement Dates FDA Received: 12/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVE 11/13 +6; ASR ACETABULAR CUPS 56; ASR UNI FEMORAL IMPL SIZE 49; SROM STM STD 36+12L 13X18
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 71 KG