MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*HEAD FEMORAL COCR 32+6; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number 52-2033

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

Patient Problems Cyst(s) (1800); Hypersensitivity/Allergic reaction (1907); Discomfort (2330); Osteolysis (2377)

Event Date 10/04/2022

Event Type  Injury  

Event Description

Clinical notification received for revision due to osteolysis.Date of implant: (b)(6) 2002.Date of revision: (b)(6) 2022.(right hip).Treatment: revision of the head and liner.

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

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records received.On (b)(6) 2002, the patient's right hip was revised to address massive osteolysis, implant loosening of both the femoral stem and acetabular cup, and large pseudocyst.The surgeon identified a large effusion representing the pseudocyst upon entering the pseudocapsule.The patient had significant osteolysis of the proximal femur, as well as osteolytic cavitary defects of the acetabulum, which were treated with femoral strut grafting (with competitor cerclage cables and trochanteric bolt) for the femoral defects, and cancellous bone grafting to address the acetabular.The femoral stem, head, acetabular cup and liner were all revised.Product details or device manufacturer of the explanted products were not provided (this is consistent with the clinical database for this revision, in which the clinical site also reported that the revised products were "unknown").Depuy s-rom stem and an s-rom arthropor 2 cup were implanted.On (b)(6) 2002, the patient's right hip was treated with a simple surgical hardware removal of the competitor trochanteric bolt, as the bolt had spontaneously begun to "back out" and loosen, causing pain.This was completed without any reported complications.On (b)(6) 2022, the patient's right hip was revised to address discomfort with eccentric polyethylene liner wear and osteolysis, and excision of a fluid-filled pseudocyst.S-rom head and moderately worn s-rom liner (with s-rom acetabular rim screw and locking pin) revised.Cup was well-fixed, well-positioned, and only slightly vertical (not mispositioned).No evidence of any altr or metallosis.No complications were reported.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the device associated with this report was received for examination.Based on the visual analysis of the provided photographic evidence for it cannot be determinate a depuy's device failure or malfunction which could contribute to reported event.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may 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.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.

• Type of Device: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15638515
• MDR Text Key: 302068212
• Report Number: 1818910-2022-20967
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295170839
• UDI-Public: 10603295170839
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K920317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 52-2033
• Device Catalogue Number: 522033
• Device Lot Number: YAL-37
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2001
• 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: S-ROM*CUP ACE,A2 L32,54DP+6.; S-ROM*HEAD FEMORAL COCR 32+6.; S-ROM*LINER LSER,10 DEG,32MM.; SROM*STMLG36+21CR8L 24X19X230N.
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 102 KG