MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM MAR LNR L 32MM+3MM 10 DEG; S-ROM HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1220-72-332
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Joint Dislocation (2374); Osteolysis (2377); Metal Related Pathology (4530); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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
Medical records received.After review of medical records, it was reported that the patient presented in er due to severe pain and dislocation.Closed reduction was performed.Mri reported of osteolysis associated with metallosis.Doi: (b)(6), 2017.Dor: none reported.Left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary : no device associated with this report was received for examination.All available x-rays were reviewed and the complaint cannot be confirmed.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.H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the blood heavy metal increased.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available x-rays were reviewed and the complaint cannot be confirmed.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.
Additional 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Medical records were received: on (b)(6) /2017, the patient had left pain and clicking, an mr of the left hip was reported to show a small hip effusion, synovial thickening within the iliopsoas bursa, along with right trochanteric bursitis.(no mention of any invasive procedure) on (b)(6) 2017, the patient had a left total hip arthroplasty to address polyethylene wear.A preoperative radiograph was reported to show some polyethylene wear.On (b)(6) 2018 the patient has a medical diagnosis of tha revision, and dislocation (no mention of when that dislocation had happened).

• Brand Name: SROM MAR LNR L 32MM+3MM 10 DEG
• Common Device Name: S-ROM HIP SYSTEM : HIP POLY ACETABULAR LINERS
• 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12487760
• Report Number: 1818910-2021-20389
• Device Sequence Number: 4081962
• Product Code: KWA
• UDI-Device Identifier: 10603295015918
• UDI-Public: 10603295015918
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K924492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/27/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 1220-72-332
• Device Catalogue Number: 122072332
• Device Lot Number: 8531505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 10/25/2021; 10/25/2021; 07/20/2023
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 10/25/2021; 11/01/2021; 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICUL/EZE BALL 32 +5 BR; S-ROM*PIN LOCK,5.0MM DIA; S-ROM*SCREW,5.0MM DIA,35 MM LG; SROM MAR LNR L 32MM+3MM 10 DEG; UNK HIP ACETABULAR CUP SROM; UNKNOWN HIP FEMORAL STEM; ARTICUL/EZE BALL 32 +5 BR; S-ROM*PIN LOCK,5.0MM DIA; S-ROM*SCREW,5.0MM DIA,35 MM LG; SROM MAR LNR L 32MM+3MM 10 DEG; UNK HIP ACETABULAR CUP SROM; UNKNOWN HIP FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male