MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 21MM MOD REV HIP BDY/BLT +30MMCOMPONENT LEVEL 9006-1-321; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6276-1-321
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.The following devices were also listed in this report: mod con dist stem 18 x 155 mm; 6276-7-018; caxk404d.V40 cocr lfit head 40mm/+12; 6260-9-440;mhkk0t.Trident 0 deg insert 40mm;623-00-40e;mje214.Primary tritanium hemi cluster hole cup 56mm;502-03-56e;mhmaad.6.5 cancellous bone screw 50mm;2030-6550-1;mhatp6.6.5 cancellous bone screw 50mm;2030-6550-1;mhr3l9.6.5 cancellous bone screw 40mm;2030-6540-1;mjd0ee.6.5 cancellous bone screw 30mm;2030-6530-1;mjar41.Trochanteric grip plate with 2;6704-3-081;g2903933.Md vit slv and 2.0mm homog cbl;6704-0-510;30898002.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Plaintiff was implanted with a howmedica restoration modular hip system, reference no.6276-1-321 upon information and belief containing a rejuvenate or abg ii modular hip stem on his right hip on or about (b)(6) 2010.Plaintiff has not had the right hip stem explanted at the present time; however, he has experience severe pain and complications related to the right hip stem and was seen for said pain on (b)(6) 2014 at (b)(6) medical center emergency room.Plaintiff hasn't been revised.This pi is for the severe pain and complications related to the restoration modular hip system.

• Brand Name: 21MM MOD REV HIP BDY/BLT +30MMCOMPONENT LEVEL 9006-1-321
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10233111
• Report Number: 0002249697-2020-01375
• Device Sequence Number: 10905880
• Product Code: LPH
• UDI-Device Identifier: 07613154057917
• UDI-Public: 07613154057917
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/06/2020

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
• Operator of Device: Health Professional
• Device Model Number: 6276-1-321
• Device Catalogue Number: 6276-1-321
• Device Lot Number: 20088901
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 07/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention