MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*PIN LOCK,5.0MM DIA; S-ROM HIP SYSTEM : HIP ACETABULAR AUGMENT

Model Number 55-0295

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Discomfort (2330)

Event Date 12/29/2020

Event Type  Injury  

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 Description

Subject id: (b)(6).Study: (b)(6).Clinical notification received for revision of left total hip to address polyethylene liner wear date of primary:(b)(6) 1983 (manufacturer unknown).Date of revision #1: (b)(6) 1997.Date of revision #2: (b)(6) 2020.(right hip).Treatment: femoral head and acetabular liner revised.

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 devices associated with this report had been implanted for more than 20 years prior a need for revision.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 ACETABULAR AUGMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12500705
• MDR Text Key: 272440638
• Report Number: 1818910-2021-20570
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295175162
• UDI-Public: 10603295175162
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963206
• 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
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 55-0295
• Device Catalogue Number: 550295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/1999
• 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: COMPETITOR DALL-MILES CABLE; S-ROM*CUP ACE,ZTT-2 L32,60DP; S-ROM*INSERT L32,10DEG,28MM 3M; S-ROM*PIN LOCK,5.0MM DIA; S-ROM*SCREW,5.0MM DIA,45 MM LG; S-ROM*SCREW,6.5MM DIA,50MM LG; TOTAL HIP BALL 28MM +5; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White