MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH COCR HEAD 28/-4 S 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 05/14/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: item#61272842; lot#3146967; bipolar insert, modular, 42/28.Item#4710500394-3; lot#ax44ch0111; optipac 40 refob bone cmt r-3.Item#0106010003; lot#3123522; avenir muller, stem, standard, uncemented, ha, 3, taper 12/14.Item#61270044; lot#3145111; bipolar shell, modular, 44.G2- germany.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 - 2023 - 00324.

Event Description

It was reported that patient underwent implantation with hip prostheses.Postoperatively, during the exercise, a decoupling of head and inlay occurred with dislocation of the hip.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00324-1.This follow-up report is being submitted to relay additional and/or corrected information.The devices have not been returned for examination due to missing patient consent.Therefore, no device examination could be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.In total three undated radiographs were provide, consisting of one ap pelvis and two ap views of the right hip, were received and evaluated by a health care professional (radiologist).The assessment identified a dislocation of the right hip arthroplasty with displacement of the acetabular implant.The prosthetic femoral head is seated within the native acetabular fossa.There is no fracture.The bone quality appears osteopenic.With the available information, the reported dislocation can be confirmed; nevertheless, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that patient underwent implantation with hip prostheses.Postoperatively, during the exercise, a decoupling of head and inlay occurred with dislocation of the hip.This resulted in revision surgery being performed six (6) days after the initial procedure.Attempts have been made and no further information has been provided.

• Brand Name: COCR HEAD 28/-4 S 12/14
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 17162820
• MDR Text Key: 317473546
• Report Number: 0009613350-2023-00325
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024393776
• UDI-Public: (01)00889024393776(17)330201(10)3148072
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 14.28.05-20
• Device Lot Number: 3148072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2023
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female